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53 Found open positions

Associate Director, Clinical Data Management

FH Vaccine and Infectious Disease Division
Category: Clinical Research Support Services
Seattle, WA, US
Job ID: 13817

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.

 

The Statistical Center for HIV/AIDS Research and Prevention (SCHARP) at Fred Hutch is a full service statistical and data management center focused on HIV prevention research. SCHARP has an annual budget of over $40 million, more than 180 employees and is currently managing over 40 active phase I – III clinical trials in over 150 clinical sites around the world. SCHARP is seeking an Associate Director, Clinical Data Management (CDM) to provide overall leadership and management of the clinical data management and safety teams (consisting of 40 staff) and direct supervision of CDM managers, the manager of Clinical Safety and Coding, and other CDM staff as needed. The incumbent will be responsible for ensuring that the CDM teams are operating efficiently and effectively and that they meet the requirements of the research protocols in a regulatory compliant manner.

Responsibilities

Leadership  

  • Provide overall strategic, organizational, and operational management and guidance to the Clinical Data Management group. 
  • Collaborate with the SCHARP Director and other senior managers to create and implement overall organizational vision and strategic direction. 
  • Foster and promote the long-term development of the Clinical Data Management team, work closely with the SCHARP Director, Senior Management Team, and the CDM managers to improve the operational effectiveness of the group.

 

Management 

  • Directly supervise Clinical Data Management and Safety and Coding managers, and other CDM staff as needed. 
  • Provide training, direction and performance management for individual employees and work with Fred Hutch Human Resources staff to facilitate recruiting efforts and staffing changes as needed. 
  • Develop and maintain CDM staff morale, engagement, and professional development. 
  • Monitor group project and protocol workflows, priorities, timelines, deliverables, documentation and resources and communicate issues regarding conflicts and/or resource limitations. 
  • Provide technical and functional oversight of the day-to-day work and work products of clinical data management staff, as needed, including clinical data collection, processing, and quality control procedures, timelines and documentation.

 

Change Management and Quality Assurance 

  • Lead departmental efforts to standardize work practices and develop standard operating procedures in conformance with GCP, GCDMP, and ICH guidelines, and that meet regulatory submission requirements, and CDISC standards. 
  • Oversee and ensure quality assurance of CDM in coordination with the Quality Management section. 
  • Prioritize and manage the implementation of SCHARP continuous quality improvement, regulatory compliance, operational effectiveness, and technical infrastructure improvement projects in clinical data management. 
  • Evaluate and identify efficiencies and process improvements including leading process improvement projects, and infrastructure and technological upgrades to improve CDM intake, workflow, documentation, tracking, and protocol management 

Qualifications

Minimum: 

  • Bachelor’s degree in related field and a minimum of 10 years of experience in clinical research, data management or related field, of which 4 years is in a leadership or management role, or equivalent combined years of education and experience.
  • Demonstrated leadership, management, supervisory, and collaboration skills across functions to drive effective and efficient Clinical Data Management practices. 
  • Excellent project management and organizational leadership and change management experience. 
  • Experience in the development and use of commercial clinical data management. Systems and/or EDC products. 
  • Advanced knowledge of clinical research, FDA, ICH, GCP, GCDMP, and related regulatory requirements and best practices.

 

Preferred: 

  • Graduate Degree in life sciences or related disciplines. 
  • 10+ years management experience in a clinical research organization. 
  • Organization strategic planning experience. 
  • Working knowledge of CDISC / CDASH, MedDRA coding, and Medidata Rave EDC. 

Biostatistician

FH Vaccine and Infectious Disease Division
Category: Biostatistics, Bioinformatics and Computational Biology
Seattle, WA, US
Job ID: 13702

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.

 

The Statistical Center for HIV/AIDS Research and Prevention (SCHARP) at Fred Hutch is a full service statistical and data management center focused on HIV prevention research. SCHARP has an annual budget of over $40 million, more than 180 employees and is currently managing over 40 active phase I – III clinical trials in over 150 clinical sites around the world. SCHARP is seeking a Statistical Research Associate (SRA) to provide statistical support to laboratory investigators researching HIV and other infectious disease vaccines under the direction of the lead statisticians. This support primarily involves analysis of biomarker data for preclinical, early phase, and post-marketing clinical studies, but can also encompass a variety of statistical requests. The SRA codes primarily in R. In addition to performing the analyses, the SRA communicates with the internal statistical team and external investigators regarding details of the data, analysis plan, and timelines. As part of a larger team of statisticians, programmers, and project managers, the SRA also contributes to an environment of mutual cooperation and respect. The SRA handles multiple projects and works efficiently in a fast-paced environment.

Responsibilities

Under limited technical direction, the SRA applies statistical and programming knowledge to various types of laboratory data and sometimes clinical data, resulting in production of a statistical report and analysis data for distribution. The SRA writes programs that are reproducible, well documented, and reusable for similar types of data. The incumbent works in close collaboration with statisticians and other programming staff within SCHARP. The SRA exercises judgment within defined SCHARP practices and policies. 
  
Responsibilities may include some or all of the following: 

  • Provide statistical analysis, written summaries and tables of results of laboratory data for use in customized statistical lab reports under the direction of other statisticians 
  • Clearly communicate statistical concepts and issues to scientists and other non-statisticians 
  • Work individually or as part of a team to resolve statistical issues pertaining to the study 
  • Brainstorm and perform exploratory analyses with guidance from the lead statistician  
  • Prioritize and manage workload on multiple project requests within deadlines 
  • Assist in the development of quality control procedures for data analysis 
  • Generate standardized code for assay data processing that can be used across studies 

Qualifications

Minimum: 

  • Master’s degree in Biostatistics or Statistics 
  • 1 year of related experience 
  • Background in statistical computing and proficiency with the statistical packages R, as with the development of statistical programs and software 
  • Excellent computer skills with the ability to optimize the use of available software 
  • Experience collaborating with others to determine what data is needed, what data exists, and how best to extract the data in a useful format 
  • Strong oral and written communication skills 
  • Organized, detail-oriented, capable of meeting tight deadlines, and work well within a team environment

 

Preferred:  

  • Master's Degree in Biostatistics and 2 or more years of related experience
  • Experience with laboratory assay data
  • Experience with creating Rmarkdown reports
  • Experience writing statistical reports
  • Experience with Git and GitHub or other version control software

Clinical Coding Specialist

FH Vaccine and Infectious Disease Division
Category: Clinical Research Support Services
Seattle, WA, US
Job ID: 12980

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. The Center’s five scientific divisions collaborate to form a unique environment for conducting basic and applied science. Vaccine and Infectious Diseases Division (VIDD) works to eliminate or minimize the impact of globally significant infectious diseases. Within VIDD is the Statistical Center for HIV/AIDS Research & Prevention (SCHARP), which provides statistical support and data management to researchers worldwide in the fight against HIV/AIDS with active studies in the U.S., Africa, Latin America, Asia and Europe. Careers Start Here.


The Statistical Center for HIV/AIDS Research and Prevention (SCHARP) at Fred Hutch is a full service statistical and data management center focused on HIV prevention research. SCHARP has an annual budget of over $40 million, more than 180 employees and is currently managing over 40 active phase I – III clinical trials in over 150 clinical sites around the world. SCHARP is seeking a Clinical Coding Specialist. The specialist is responsible for abstracting and coding Adverse Events (AEs) and Concomitant Medications (ConMeds) information from clinical trials data using the Medical Dictionary for Regulatory Activities (MedDRA) and WHO Drug Dictionary (WHO-DD) tools. Assists in coordinating the collection and entry of study site-specific laboratory reference ranges. Depending on experience, may also assist in the management of the lab normal range database and train and mentor junior staff.

Responsibilities

The incumbent works with limited supervision in performing daily work assignments.

 

  1. Using the clinical coding tools and other established SCHARP guidelines, select the clinical code most closely aligned with the adverse event being reported.
  2. Review reported AE and ConMeds to identify inadequate, ambiguous or unclear medical terms/medications and generates coding queries as necessary.
  3. Manages queries related to coding terms, through closure; including entering queries into EDC and triaging site or Medial Monitor questions.
  4. Review coded data to ensure coding is both correct and codes are applied consistently across all studies in accordance with established work instructions.
  5. On request, assist other members of the Clinical Coding & Safety staff or SCHARP staff with information from the MedDRA and WHO-DD Coding tools.
  6. Participate in MedDRA and WHO-DD trainings to remain up to date on procedural and coding changes, as well as standard industry practices.
  7. Participate on SCHARP working groups and special projects, as needed.
  8. Assists in coordinating the collection and entry of study site-specific laboratory reference ranges.
  9. Conduct all job duties within context of Good Clinical Practice (GCP) and according to SCHARP SOPs and guidelines.
  10. Works mostly independently on daily activities with minimal instruction. Exercises good judgment within scope of responsibilities to determine appropriate actions.

Qualifications

Minimum:

  • Bachelors or higher required, in related field desired
  • Minimum of 2 years of Data Management experience in clinical trials
  • Minimum of 1 year of experience performing clinical coding in clinical trials and knowledge of MedDRA and WHO Drug coding practices
  • Familiar with Clinical Coding Dictionaries (MedDRA and WHO Drug) and best Clinical Data Management practices
  • Knowledge of and experience with clinical coding dictionaries and terminology
  • Familiarity with GCP, ICH and FDA requirements as they apply to clinical data
  • Demonstrated technical skills (EDC systems, MS Excel, Word, PowerPoint), Medidata Coder and Medidata Lab Admin experience desired
  • Regular interaction with Data Management Groups
  • Excellent written and oral communication skills
     

Preferred:

  • 4+ years of Data Management experience in clinical trials.
  • 3+ years of experience performing clinical coding in clinical trials and knowledge of MedDRA and WHO Drug coding practices
  • Fully conversant of Clinical Coding Dictionaries (MedDRA and WHO Drug) and best Clinical Data Management practices
  • Knowledge of and experience with developing and maintaining coding guidelines, quality control processes and auditing procedures.

Clinical Data Operations Project Manager

FH Vaccine and Infectious Disease Division
Category: Biostatistics, Bioinformatics and Computational Biology
Seattle, WA, US
Job ID: 13856

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first and largest cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network (HVTN). Careers Start Here.


The Biostatistics, Bioinformatics and Epidemiology (BBE) program in the Vaccine & Infectious Disease Division (VIDD) is seeking a Data Operations Project Manager to manage clinical research data-related projects and deliverables in collaboration with BBE faculty and external collaborators evaluating vaccines to prevent HIV, Tuberculosis and other infectious diseases.

 

Some travel, including international travel, may be required. (less than 10% time). Flexible work hours required due to occasional international conference calls.

Responsibilities

The Data Operations Project Manager will apply knowledge of clinical data management & research operations to

  • Prioritize and monitor data operations activities, ensuring that research needs and time lines are met.
  • Serve as a liaison with internal project teams and external organizations.
  • Define and track deliverables, budgets, milestones, and timelines for new and existing research projects.
  • Review project plans and data specifications to identify discrepancies and inconsistencies.
  • Coordinate and oversee the investigation and resolution of data discrepancies.
  • Manage projects, plan and facilitate meetings, and document activities described above.
  • Perform other tasks related to study data management operations, as required.

Qualifications

Required:

  • Bachelor's degree in biological science-related field
  • Five years of related experience in a research setting
  • Strong interpersonal and organizational skills
  • Excellent written and verbal communication skills
  • Experience with Microsoft Office suite, especially Word and Excel
  • Experience working with clinical trial data in a multidisciplinary team environment
  • Experience reading and writing technical documents
  • Experience managing projects with multiple stakeholders
  • Critical thinking skills and collaborative approach to problem solving


Desired:

  • Experience with and knowledge of clinical trial data entry and management systems (e.g. Medidata Rave)
  • Familiarity with CDISC data standards
  • Experience managing budgets
  • Experience with Business Intelligence software (e.g. Power BI, Tableau)

Clinical Quality Assurance Specialist

FH Vaccine and Infectious Disease Division
Category: Quality
Seattle, WA, US
Job ID: 14027

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.

 

The Statistical Center for HIV/AIDS Research and Prevention (SCHARP) at Fred Hutch is seeking a Clinical Quality Assurance Specialist to join the Quality Assurance Team to provide quality support of clinical trial research.

Responsibilities

Works with the Quality Assurance Team to develop, implement, maintain and monitor the comprehensive quality management system (QMS), including

  • SOP Document Control
  • Employee SOP/Compliance Training
  • Record Maintenance
  • CAPA Implementation and Reporting
  • Internal Quality Audits
  • External Audits and Inspections
  • Vendor Audits
  • System Validation Review and Archive
  • Quality Department Process Improvement Initiatives
  • Org Charts, CVs, Job Descriptions, Debarment Checks Maintenance
  • Performs other responsibilities as required

Qualifications

Bachelor's degree* with 2+ years of experience implementing typical quality assurance activities, including:

  • Facilitating internal audits of processes, study documentation, and records, as well as, maintenance of related records.
  • Preparing and/or participation in client or regulatory audits and maintenance of related records.
  • Identification and reporting of incidents/deviations, maintenance of related reports and documents, implementation of corrective and/or preventive actions.
  • Assignment and tracking of staff training and maintenance of training records.
  • Review, development and revision of procedures (SOPs), as well as, maintenance of controlled documents and related records.
  • Qualification of suppliers/vendors and maintenance of related documentation.
  • Review of system validation documentation and maintenance of related records.

*Progressive experience in implementing quality systems may substitute educational requirement.

 

Seeking Key Characteristics

  • Effective written and verbal communication skills 
  • Proficiency in MS Office Applications
  • Ability to multi-task and meet target dates
  • Strong organizational skills
  • Ability to maintain accurate and detailed records

Preferred Experience, but not required

  • Familiarity with Good Clinical Practices (GCP) in a clinical trial atmosphere
  • Experience using MasterControl or similar eQMS system

Clinical Research Coordinator I/II--Infectious Disease Sciences

FH Vaccine and Infectious Disease Division
Category: Clinical Research Support Services
Seattle, WA, US
Job ID: 13658

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.


The Clinical Research Coordinator I/II (CRC I/II) will coordinate day-to-day activities for assigned clinical research protocols for the Infectious Disease Sciences Program while demonstrating competence in clinical research skills, problem-solving, and priority setting.

Responsibilities

The incumbent will participate in the planning, coordination, and implementation of complex investigator-initiated, industry-sponsored, and cooperative group clinical research studies involving human subjects. This individual will work under the supervision of the Clinical Trial Program Manager and will be required to perform their responsibilities with independence within the scope of study protocol(s) and institutional guidelines. Collaborate with a multi-disciplinary team and provide guidance to other study staff in carrying out research implementation tasks. The incumbent will some or all the following responsibilities:

 

Study Conduct / Clinical Research Practice

  • Work independently in performing daily responsibilities required to plan and execute investigator driven/industry-based clinical research trials and non-intervention protocols.
  • Coordinate research and administrative activities related to studies, ensuring all projects are completed according to project timelines.
  • Serve as project liaison, representing the project to other center departments, funding sources, affiliated individuals or institutions, and outside organizations.
  • On assigned projects, act as the main protocol resource person for the investigator and/or research sponsor, research subjects, local and central labs, monitors, primary care teams, and investigational pharmacy staff.
  • Collaborate with investigators and coworkers to ensure completion of study activities
  • Train others as needed and develop standard operating procedures (SOP) or other necessary documents for standardized study conduct.
  • Screen and recruit subjects either within the consortium or the community dependent upon study specific requirements, enroll, and follow research subjects, complete case report forms (CRFs), place physician orders, coordinate research study visits, communicate with the primary care teams, investigational pharmacy staff and research subjects.
  • Travel to University of Medical Center, Seattle Children’s, and Seattle Cancer Care Alliance will be required for the enrollment of study subjects.
  • Ensure accurate enrollment records are maintained and up to date.
  • Coordinate specimen collection, transport, processing, storage, and shipment procedures according to protocol requirements. Track and maintain research supplies.
  • Create source documents or CRFs as needed to promote efficient data collection and entry.
  • Review CRFs to ensure completeness, accuracy, and compliance with Good Clinical Practice.
  • Identify and report any adverse events in accordance with protocol, regulatory guidelines, and institutional policy.


Protocol Development and Implementation

  • Help develop and review research protocols for feasibility and collaborate with study leadership to develop the study budget and implementation plans.
  • Develop and maintain tools for study implementation, which may include data collection tools, study reference materials, and study specific orders. Revise and utilize tools as necessary to fulfill the aims of the clinical trial.


Budget and Billing

  • Prepare requests for research prices on study activities and coordinate the research billing start-up process.
  • Review, reconcile, and approve research study bills. Work closely with the IDS fiscal staff to ensure accurate research billing and reimbursement.


Regulatory Compliance and Documentation

  • Facilitate protocol monitoring visits and collaborate with study monitors to resolve data discrepancies and procedural issues.
  • Provide input to the regulatory coordinator on protocol document submissions and continuing review reports.
  • Prepare or assist in preparing consent forms, continuation review reports, protocol modifications, serious adverse event reports, and other study reports.


Other duties which may be required:

  • Perform retrospective chart review as required
  • Travel for investigator meetings
  • Will require weekends and holiday coverage for clinical studies.
  • Other duties as assigned

Qualifications

  • Clinical Research Coordinator I Minimum Education/Experience: BS or higher degree required in scientific/medical field. Previous work experience in a clinical research setting required.
  • Clinical Research Coordinator II Minimum Education/Experience: Bachelor’s degree in scientific/medical field or equivalent experience/education. Master’s degree in healthcare related field preferred, particularly in the area of epidemiology. Minimum of three years post-master’s or five years post-bachelor’s experience in clinical study/trials coordination or related field.
  • Computer experience including electronic CRF, MS Office including Excel, Outlook, PowerPoint and Access.
  • Knowledge using REDCap databases is desirable.
  • Excellent written and communication skills, attention to detail, high-level organization, leadership ability, and the flexibility to work in collaboration with a multi-disciplinary team.
  • Desire Certified Clinical Research Coordinator (ACRP), Certified Clinical Research Professional (SOCRA), or equivalent certification

 

Clinical Research Coordinator II

FH Vaccine and Infectious Disease Division
Category: Clinical Research Support Services
Seattle, WA, US
Job ID: 13742

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.


The Clinical Research Coordinator I/II (CRC I/II) will coordinate day-to-day activities for assigned clinical research protocols for the Infectious Disease Sciences Program while demonstrating competence in clinical research skills, problem-solving, and priority setting

Responsibilities

The incumbent will participate in the planning, coordination, and implementation of complex investigator-initiated, industry-sponsored, and cooperative group clinical research studies involving human subjects. This individual will work under the supervision of the Clinical Trial Program Manager and will be required to perform their responsibilities with independence within the scope of study protocol(s) and institutional guidelines. Collaborate with a multi-disciplinary team and provide guidance to other study staff in carrying out research implementation tasks. The incumbent will some or all the following responsibilities:

 

Study Conduct / Clinical Research Practice

  • Work independently in performing daily responsibilities required to plan and execute investigator driven/industry-based clinical research trials and non-intervention protocols.
  • Coordinate research and administrative activities related to studies, ensuring all projects are completed according to project timelines.
  • Serve as project liaison, representing the project to other center departments, funding sources, affiliated individuals or institutions, and outside organizations.
  • On assigned projects, act as the main protocol resource person for the investigator and/or research sponsor, research subjects, local and central labs, monitors, primary care teams, and investigational pharmacy staff.
  • Collaborate with investigators and coworkers to ensure completion of study activities
  • Train others as needed and develop standard operating procedures (SOP) or other necessary documents for standardized study conduct.
  • Screen and recruit subjects either within the consortium or the community dependent upon study specific requirements, enroll, and follow research subjects, complete case report forms (CRFs), place physician orders, coordinate research study visits, communicate with the primary care teams, investigational pharmacy staff and research subjects.
  • Travel to University of Medical Center, Seattle Children’s, and Seattle Cancer Care Alliance will be required for the enrollment of study subjects.
  • Ensure accurate enrollment records are maintained and up to date.
  • Coordinate specimen collection, transport, processing, storage, and shipment procedures according to protocol requirements. Track and maintain research supplies.
  • Create source documents or CRFs as needed to promote efficient data collection and entry.
  • Review CRFs to ensure completeness, accuracy, and compliance with Good Clinical Practice.
  • Identify and report any adverse events in accordance with protocol, regulatory guidelines, and institutional policy.


Protocol Development and Implementation

  • Help develop and review research protocols for feasibility and collaborate with study leadership to develop the study budget and implementation plans.
  • Develop and maintain tools for study implementation, which may include data collection tools, study reference materials, and study specific orders. Revise and utilize tools as necessary to fulfill the aims of the clinical trial.


Budget and Billing

  • Prepare requests for research prices on study activities and coordinate the research billing start-up process.
  • Review, reconcile, and approve research study bills. Work closely with the IDS fiscal staff to ensure accurate research billing and reimbursement.


Regulatory Compliance and Documentation

  • Facilitate protocol monitoring visits and collaborate with study monitors to resolve data discrepancies and procedural issues.
  • Provide input to the regulatory coordinator on protocol document submissions and continuing review reports.
  • Prepare or assist in preparing consent forms, continuation review reports, protocol modifications, serious adverse event reports, and other study reports.


Other duties which may be required:

  • Perform retrospective chart review as required
  • Travel for investigator meetings
  • Will require weekends and holiday coverage for clinical studies.
  • Other duties as assigned

Qualifications

  • Clinical Research Coordinator I Minimum Education/Experience: BS or higher degree required in scientific/medical field. Previous work experience in a clinical research setting required.
  • Clinical Research Coordinator II Minimum Education/Experience: Bachelor’s degree in scientific/medical field or equivalent experience/education. Master’s degree in healthcare related field preferred, particularly in the area of epidemiology. Minimum of three years post-master’s or five years post-bachelor’s experience in clinical study/trials coordination or related field.
  • Computer experience including electronic CRF, MS Office including Excel, Outlook, PowerPoint and Access.
  • Knowledge using REDCap databases is desirable.
  • Excellent written and communication skills, attention to detail, high-level organization, leadership ability, and the flexibility to work in collaboration with a multi-disciplinary team.
  • Desire Certified Clinical Research Coordinator (ACRP), Certified Clinical Research Professional (SOCRA), or equivalent certification

Clinical Research Coordinator II, Hill Group

FH Vaccine and Infectious Disease Division
Category: Clinical Research Support Services
Seattle, WA, US
Job ID: 13857

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.


The position will work directly with an Assistant Member in the Infectious Disease Sciences Program in the Vaccine and Infectious Disease Division to provide support to the PI and research staff in the development, implementation and management of his diverse research portfolio, including research studies and clinical trials.


The Clinical Research Coordinator (CRC) will be responsible for providing support on all aspects of research study and clinical trial development and implementation. Primary responsibilities of the CRC will include assistance with the planning, coordination, implementation, and close-out (e.g. presentation of data, manuscript writing) of industry-sponsored clinical trials, in addition to retrospective and prospective observational or investigator-initiated interventional studies. Additional responsibilities will include communicating with internal and external collaborators and supporting study personnel in the preparation of regulatory documentation and audits if applicable.


Under the supervision of the Research Manager and the PI, the CRC will manage a portfolio of clinical research projects and will be required to perform their responsibilities with a high level of independence within the scope of study protocol(s) and institutional guidelines. The position will include interaction with patients, physicians, researchers, and other clinical providers and support staff within and outside of the Fred Hutch/ Seattle Cancer Care Alliance (SCCA) / UW system including the SCCA Patient Care Services.

Responsibilities

  • Assist the research manager with preparing start-up documentation including IRB documents, eligibility checklists, study procedures/SOPs, study-specific clinic orders and study calendars (if not completed by the Clinical Research Manager)
  • Screens and registers patients; ensures eligibility requirements are met
  • Ability to consent patients and assures consent forms are completed correctly and in entirety
  • Schedules study related clinic procedures such as blood draws, infusions and imaging according to protocol requirements; coordinates with clinic staff to ensure proper documentation and timing of research-related procedures
  • Perform review of medical charts using ORCA/MINDscape and enter data in REDCap, Excel or other study-related databases
  • Abstracts data from medical records to complete study-specific case-report form (CRFs) (electronic and/or paper) in timely and accurate manner; maintains shadow chart with source documents
  • Maintain study and specimen tracking and inventory records for biospecimens pulled from repository.
  • Assemble study kits for clinical trials.
  • Perform basic processing and banking of lab specimens and associated record keeping
  • Collaborates with study sponsor/consortium delegate to assist with study monitoring visits and responds to findings
  • Creates and maintains patient tracking tools; communicates status to investigators, management and relevant departments
  • Manages study documentation throughout study life cycle including IRB annual renewals, modifications, patient study charts and regulatory binder
  • Liaises with study sponsor, investigator(s), research manager and members of study team to communicate timelines, expectations and study status
  • Acts as a resource to physicians, investigators, other staff members, and other organizations regarding protocol procedures, data collection requirements and other study related operations
  • Keeps knowledge and skills current by completing mandated training and attending meetings with the study team and the Consortium, such as the monthly coordinator meeting, relevant lectures, faculty and administrative presentations, and other opportunities of interest
  • Perform other duties as assigned.

Qualifications

Clinical Research Coordinator II Minimum Education/Experience

 

Bachelor’s degree in scientific/medical field or equivalent experience/education. Master’s degree in healthcare related field is preferred. Minimum of three years post-master’s or five years post-bachelor’s experience in clinical study/trials coordination or related field.

  • Clinical research related certification is preferred.
  • Experience with industry-sponsored clinical trials and documentation of case report form (eCRF) in study electronic data capture (EDC) system
  • Ability to work in teams and independently, flexible hours at times in support of clinical trials and regulatory and related compliance
  • Strong attention to detail and project management skills and experience is required
  • Well-organized and ability to juggle numerous tasks, often with conflicting and competing deadlines
  • Strong written and verbal communication skills
  • Strong computer skills, including proficiency in the Office Suite, and experience working with excel and databases (preferably REDCap)
  • Knowledge of federal regulations and guidelines that govern clinical research, including GCP and human subjects research       

Data Scientist I

FH Vaccine and Infectious Disease Division
Category: Biostatistics, Bioinformatics and Computational Biology
Seattle, WA, US
Job ID: 14216

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.

 

Biostatistics, Bioinformatics and Epidemiology (BBE) at Fred Hutch is seeking an experienced Data Scientist to work on multiple projects investigating the immunological correlates of vaccine protection for novel tuberculosis and HIV vaccine candidates. The immune response to a vaccine can be highly variable across individuals, particularly for new vaccines that are in active development. Understanding the factors that impact vaccine response and identifying the features of the immune response that confer protection can provide critical feedback for vaccine refinement. As part of the HIV Vaccine Trials Network supported by the NIH Division of AIDS and the Global Health Vaccine Accelerator Program, supported by the Bill and Melinda Gates Foundation we are leading major computational efforts to integrate immunological datasets generated from human vaccine trials. Analysis datasets include those generated by multicolor flow cytometry, transcriptomics/RNAseq, T cell receptor repertoire sequencing, mass spectrometry, microbiome 16S and metagenomic sequencing, and multiplexed systems serology among others.

Responsibilities

The Data Scientist works closely with the PI, a computational biologist and biostatistician, and a growing team, to develop data pipelines, plan and conduct analyses, design and implement data visualizations, and help prepare figures for funding proposals and publication. The ideal candidate should have an appetite to understand and analyze new types of data. 

Qualifications

  • M.A., M.S. in computational biology, biostatistics, computer science, data science, bioinformatics or a related field. Candidates with Ph.D. also encouraged to apply.
  • 2 - 4 years of hands-on biological data science experience
  • Proficiency in Python and/or R programming, with knowledge of the appropriate tools and libraries for working with biological data
  • Demonstrated rigor and reproducibility through well organized and well documented code and/or committed to a public code repository (e.g. github)
  • Experience analyzing next-generation sequencing data (e.g. transcriptomics, or immune repertoire)
  • Preference for candidates having familiarity with dimensionality reduction, regression models, machine learning and/or cloud infrastructure for scalable scientific computing
  • Outstanding organizational skills, attention to detail and effective communication are essential
  • Eagerness to learn about immunology, vaccines, microbial ecology, biostatistics or whatever the science demands

Director of Program Operations, Biostatistics, Bioinformatics and Epidemiology (BBE) Program

FH Vaccine and Infectious Disease Division
Category: Executive and Management
Seattle, WA, US
Job ID: 14304

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.


The Program Operations Director for the Biostatistics, Bioinformatics and Epidemiology (BBE) Program within the Vaccine and Infectious Disease Division (VIDD) at Fred Hutch oversees a comprehensive and complex array of program activities for an annual portfolio of over $30M in direct cost revenue and administrative operations including strategy, financial, grants and contracts, regulatory and administrative functions for a broad program comprised of separate but linked departments. This position works with senior scientific leadership to translate science into strategy while responsible for the overall operations of administration, finance, grants and business analytics for the program. This position requires an understanding of federal regulatory requirements, performance management, administrative systems and program management, and broad experience with a range of business functions and systems, including program leadership, strategic planning, budgeting, fiscal analysis, human resources management, and communication. This position reports to the Senior Operations Director for VIDD.

Responsibilities

Works with overarching guidance from Principal Investigators (PIs) and the Division’s Senior Operations Director to independently plan and oversee administrative operations. Works through subordinate managers to ensure consistent, efficient and compliant administration of all work units within the program. Sets functional strategies and objectives on operational plans that align with overall Division and organizational strategies. Provides input to Division-level strategic planning. More detailed responsibilities include:

 

Program Oversight

  1. Develop and manage all BBE Program activities to ensure compliance with all federal, sponsor and Fred Hutch requirements and guidelines and ensure operational consistency across the program
  2. Provide effective and inspiring leadership by being actively involved in all programs, developing a broad and deep knowledge of all aspects of operations
  3. Supervise staff, including, hiring, training, mentorship, evaluating performance, handling disciplinary action, layoff and termination issues
  4. Oversee grant support activities for the program including: grant preparation, budget development/management, forecasting, reporting and report tools development
  5. Ensure the adherence to regulatory compliance procedures throughout the program
  6. Through subordinate managers, direct administrative activities for the program including: oversight of agency site reviews, human resources management activities, training and communication of Center policies, and administrative process improvement
  7. Apprise VIDD leadership of programmatic activities, challenges and accomplishments regularly

 

Strategic Planning

  1. Working with faculty and leadership from BBE, VIDD and the Center, create strategic plans and implement processes to achieve the initiatives and objectives set forth in each plan
  2. Participate in groups and committees across the Division and/or Center to support strategic and process improvement initiatives
  3. Synergize with other programs and participate in strategic planning for the Division
  4. Develop and implement a system for tracking and reporting on the progress of strategic plan implementation
  5. Plan and facilitate quarterly meetings for the Strategic Alliance within BBE that brings a leadership team together across multiple network grants 

 

Faculty Support

  1. Coordinate faculty recruiting activities for the program and support the Division office in administration of faculty promotions
  2. Assist the BBE Program Head in planning all BBE faculty meetings; attend program meetings and events to stay abreast on all milestones, activities and needs for the BBE faculty
  3. Support faculty in cultivating and managing relationships with public and private funders to secure and expand recurring revenue streams
  4. Assist the Fred Hutch Philanthropy and Marketing departments in cooperation with the Division to ensure all BBE achievements and donor relationships are appropriately highlighted and managed
  5. Seek new funding opportunities for the program as appropriate

 

Program Operations/Other

  1. Oversee financial operations for the program including: forecasting, management, reporting, reconciliations, purchasing, and vendor contract management
  2. Contribute to space allocation and planning decisions
  3. Oversee the HR systems and practices within BBE
  4. Provide financial and overall business strategy advice to program leaders and teams
  5. Participate in Division and Center-led meetings and committees and special projects
  6. Other duties as assigned

Qualifications

Minimum qualifications:

  • Bachelor’s degree in business, public administration or a related field
  • Minimum of 8-10 years of federal research administration management experience
  • Minimum of 3-5 years of supervisory and leadership experience
  • Demonstrated success managing and engaging diverse stakeholders across a complex research portfolio
  • Experience with translating science into strategy in creating and executing strategic plans
  • Strong communication and budgetary skills

 

Preferred qualifications:

  • Master’s degree preferred
  • 3-5 years of experience in supporting faculty in an academic environment
  • Experience identify areas for process improvement and implementing associated change management strategies to successfully rollout and sustain initiatives

 

Key skills and abilities:

  • Excellent written and verbal communication skills
  • Strong background in data analytics and visualization
  • Advanced experience with Microsoft suite (Excel, Powerpoint, Access, SharePoint, etc)
  • Ability to create a positive work culture
  • Flexibility and adaptability
  • Ability to multi-task in a fast-paced environment
  • Outstanding interpersonal skills
  • Positive attitude and sense of humor

HIV Outreach Specialist (part-time)

FH Vaccine and Infectious Disease Division
Category: Clinical Research Support Services
Seattle, WA, US
Job ID: 13186

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.


The Seattle HIV Vaccine Trials Unit is seeking a committed, energetic person to join our community outreach team. 

Responsibilities

The Recruiter’s primary responsibilities will be to recruit participants for our groundbreaking HIV vaccine studies.  Recruitment will occur in local venues that may include street locations, community events, community based organizations, public clinics as well as bars, dance clubs, and sex clubs.  Recruitment efforts will target diverse populations according to the demands of the current studies.  Work will include some administrative duties.

Qualifications

Minimum Qualifications

  • Must be at least 21 years old
  • Possession of a high school diploma or equivalent
  • Excellent verbal and written communication skills
  • Candidates for the position must be willing to learn a variety of skills related to recruiting, counseling and providing HIV/STD health education, and details about our research studies

Preferred Qualifications

  • Familiarity with gay community venues preferred
  • Previous experience recruiting for clinical trials
  • Previous experience working with men who have sex with men (MSM)
     

Flexible schedule will include weekday, nights and weekends on a “as needed” basis.  Knowledge of and sensitivity to youth, racial, ethnic, cultural, and sexual diversity is essential.

Junior EDC Programmer

FH Vaccine and Infectious Disease Division
Category: Information Technology
Seattle, WA, US
Job ID: 13529

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.

 

The Statistical Center for HIV/AIDS Research and Prevention (SCHARP) at Fred Hutch is a full service statistical and data management center focused on HIV prevention research. SCHARP has an annual budget of over $40 million, more than 180 employees and is currently managing over 40 active phase I – III clinical trials in over 150 clinical sites around the world.

 

The Junior Electronic Data Capture (EDC) Programmer is an entry level position that supports the SCHARP clinical data management team.  They work with the EDC Programming team to configure and program EDC clinical data management systems in support of clinical trials run by SCHARP and its partners.  This position assists with configuration and programming of new study builds and post-production changes in various EDC systems.  In addition, this role performs quality check activities on configuration and programming work performed by fellow EDC Programming team members. 

Responsibilities

  • Configure and program clinical trial forms, visit schedules, edit checks and other study requirements in EDC systems using applied knowledge or programming and data standards.
  • Performs verification of quality and completeness of study deliverables prior to release.
  • Performs peer review for configuration and programming completed by other EDC programmers for both new study builds and post-production changes.
  • Support clinical programming requests from study teams as assigned, applying knowledge of EDC tools and data standards to complete requests in the timelines defined.
  • Perform EDC Operational Support for EDC systems and modules including but not limited to: Medidata (Rave, Balance, Business Objects 4, PDF Generator, iMedidata, Translations Workbench, Reporting) and Forte EDC.
  • Perform user and site administration to include site set up and assignment of roles, permissions and training/elearning requirements.
  • Supports other activities as assigned.

Qualifications

Minimum Qualifications

  • Bachelor’s degree or a minimum of 1 year related experience in computer science, or a scientific, technical, or health-related field
  • Fundamental understanding of clinical trials
  • Excellent written & oral communication skills including grammatical/ technical writing skills
  • Working knowledge of Microsoft Word, Excel and PowerPoint
  • Effective time management and organizational skills
  • Must work well independently and be self-motivated
  • Candidates should be detail-oriented with strong analytical and critical thinking skills

 

Preferred Qualifications

  • Demonstrated programming skills (C#, SQL, or similar programming experience)
  • Experience with EDC software
  • Experience with Data Management tools or best practices

Lab Aide (Work Study)

FH Vaccine and Infectious Disease Division
Category: Laboratory Research Sciences
Seattle, WA, US
Job ID: 14242

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.

Responsibilities

The Lund Laboratory is recruiting a work-study student to assist with basic laboratory maintenance. This may include:

  • Provide basic support to the laboratory
  • Assist with murine colony
  • Assist with genotyping/PCR
  • Stock lab products
  • Autoclave and remove biohazard trash
  • Prepare reagents
  • Perform general lab maintenance/upkeep
  • Assist with set-up of experiments and work with biohazardous materials, HIV and HSV
  • Perform other duties as assigned

Qualifications

Off-Campus Work Study authorization is required for this position. All students must provide a Financial Aid Award Letter or an Authorization to work off-campus to verify their eligibility if selected for this position.

 

  • A high school diploma or GED is required.
  • Currently enrolled in college.
  • No previous experience is necessary.
  • Knowledge of computer usage (especially use of spreadsheets and databases) is highly desirable.
  • Accuracy and attention to detail is essential.

Lab Aide (Work Study)-Boeckh Lab

FH Vaccine and Infectious Disease Division
Category: Laboratory Research Sciences
Seattle, WA, US
Job ID: 14283

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.


The Boeckh lab, a busy, diverse, applied clinical research lab, is seeking a work-study student to assist with our work studying viral infections in immunocompromised populations. The successful candidate will work collaboratively as part of a team to ensure that clinical research specimens are acquired, processed and stored according to a wide variety of research protocols. The candidate will also help operate the Infectious Disease Sciences Biospecimen Repository, a valuable resource that includes more than 300,000 biospecimens spread across 20+ freezers that have been collected over a 40-year period. With interest and experience in our lab, the individual may assist with additional opportunities in research. This position offers exposure to faculty and staff across a broad range of careers in clinical research and is an excellent opportunity for anyone considering a future in clinical research or medicine.


Ideal candidates will be available for 12-19 hours per week. A reliable schedule with fixed hours in the afternoon each week (minimum of two days) is essential (can change by school term). Early evening hours are a possibility once training is complete.

Responsibilities

  • Process specimens for research use according to a wide variety of protocols
  • Maintain study and specimen tracking and inventory records
  • Put together sampling kits and distribute to study sites/patients
  • Review and improve inventory of existing biospecimen repository collections
  • Locate and retrieve specimens in response to investigator requests
  • General lab and equipment maintenance
  • Assist with research projects as directed

Qualifications

Off-Campus Work Study authorization is required for this position. All students must provide a Financial Aid Award Letter or an Authorization to work off-campus to verify their eligibility if selected for this position.

 

  • Must have a high school diploma or GED, with an interest in laboratory or clinical research and healthcare.
  • Preferred candidates will be enrolled in a college program (university or community college).
  • Experience with Microsoft Office Suite (especially Excel and Access) and effective verbal and written communication skills are also desired.
  • The ideal candidate will be skilled at organizing and prioritizing work in a high throughput setting, independent and highly motivated.  Accuracy and attention to detail is essential.

Lab Data Coordinator

FH Vaccine and Infectious Disease Division
Category: Clinical Research Support Services
Seattle, WA, US
Job ID: 14212

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.

 

The Statistical Center for HIV/AIDS Research and Prevention (SCHARP) at Fred Hutch is a full service statistical and data management center focused on HIV prevention research. SCHARP has an annual budget of over $40 million, more than 180 employees and is currently managing over 40 active phase I – III clinical trials in over 150 clinical sites around the world. SCHARP is seeking a Lab Data Coordinator. The Lab Data Coordinator (LDC) monitors the collection and processing of and performs routine data entry and quality control of laboratory specimen and assay data pipelines at the Statistical Center for HIV/AIDS Research and Prevention (SCHARP). The LDC will work within a network/study/research protocol team to support the policies and goals of each project assigned study or project. She/He will develop and maintain successful working relationships with protocol their teams and specific research sites to ensure and maintain data integrity and quality.

Responsibilities

The Lab Data Coordinator will be part of a team of data coordinators and data managers who work closely with programmers to oversee all SCHARP laboratory data pipelines. The incumbent will work under the supervision of the Lab Data Management leadership and the mentorship of the Sr. Lab Data Coordinators and lab data managers. She/he will refer all non-routine decisions for the management of data to study/protocol leads and/or departmental leadership.

 

Responsibilities may include:

  • Attend study team meetings and conference calls and with guidance, serve as a LDM representative.
  • Serve as a liaison between SCHARP study teams and external collaborators to establish and monitor specimen data pipelines and assay data from clinical trials and associated specimen repositories.
  • Oversee and distribute standardized specimen data discrepancy reports.
  • Work with external labs, SCHARP lab programmers and clinical data managers to investigate and resolve data discrepancies and troubleshoot issues as needed.
  • Identify opportunities for process improvements and collaborate to develop and implement solutions.
  • Work with SCHARP lab data managers, specialists and programmers to develop specifications / requirements for lab data management processing and quality control systems
  • Act as a liaison between the SCHARP lab data management unit and clinical research sites or external labs; and with supervision represent LDM on SCHARP study teams and in internal and external meetings.
  • Help maintain lab, assay and specimen metadata.
  • Respond to and resolves quality control queries from labs.
  • Provide operational support to labs for tools that SCHARP maintains and operates, including Atlas and custom SCHARP tools.
  • With supervision, develop Data Transfer Plans (DTPs) and other documentation associated with specimen and assay data transfers.
  • Escalate issues to the Lab Data Management leadership as needed.
  • Adhere to quality assurance procedures, standard operating procedures, and work practice guidelines and support documentation of these efforts.

Qualifications

Minimum Qualifications

  • Bachelor’s degree in biological sciences, or equivalent
  • Minimum 2 years of clinical or lab data management experience
  • Demonstrated ability to work independently and as part of a team
  • Demonstrated ability to manage multiple projects and competing priorities
  • Must be flexible, work well in a team environment, and be capable of meeting tight deadlines
  • Must be organized and detail-oriented, with excellent oral and written communication skills

Lead Data Standards Analyst

FH Vaccine and Infectious Disease Division
Category: Clinical Research Support Services
Seattle, WA, US
Job ID: 13820

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. The Center’s five scientific divisions collaborate to form a unique environment for conducting basic and applied science. Vaccine and Infectious Diseases Division (VIDD) works to eliminate or minimize the impact of globally significant infectious diseases. Within VIDD is the Statistical Center for HIV/AIDS Research & Prevention (SCHARP), which provides statistical support and data management to researchers worldwide in the fight against HIV/AIDS with active studies in the U.S., Africa, Latin America, Asia and Europe. Careers Start Here.

 

The Statistical Center for HIV/AIDS Research and Prevention (SCHARP) at Fred Hutch is a full service statistical and data management center focused on HIV prevention research. SCHARP has an annual budget of over $40 million, more than 180 employees and is currently managing over 40 active phase I – III clinical trials in over 150 clinical sites around the world. SCHARP is seeking is seeking a Lead Data Standards Analst. Under minimal supervision, the Lead Data Standards Analyst oversees the coordination and management of clinical data standards and production of standard datasets within SCHARP. The incumbent provides subject matter expertise in CDISC data standards, leads coordination efforts with SCHARP staff and network partners to standardize the collection and tabulation of clinical trials data, chairs the Data Standards Committee to govern CRF alignment with CDASH and change control for SCHARP SDTM and ADaM specifications, trains others in CDISC standards and SCHARP dataset configurations, reviews and approves draft SDTM and ADaM metadata and conversion specifications prior to implementation, configures data transformations to provision SCHARP SDTM data tables from CRF and other data pipelines to SCHARP Programmers and Statistical Research Associates via a clinical data warehouse, and may supervise Data Standards Analysts in support of above described activities.


Core to the role is a deep understanding of data standards and data transformations, the ability to communicate effectively, work collaboratively with colleagues and be responsive to the needs of both internal and external customers within an environment of mutual cooperation and respect.

Responsibilities

  • The Lead Data Standards Analyst ensures that SCHARP studies produce high-quality CDISC datasets aligned with SCHARP standards and compliant with the latest published electronic regulatory submissions standards including:
    • CDISC Clinical Data Acquisition Standards Harmonization (CDASH), Study Data Tabulation Model (SDTM), Analysis Data Model (ADaM), and Define-XML.
    • Controlled Terminology (CT) published by CDISC and NCI, as well as SCHARP-defined terminology
    • Electronic Common Technical Document (eCTD), Study Data Standards Documents, and other electronic submissions guidance issued by drug and medical device governing authorities.
  • As Chair of the Data Standards Committee, governs the process for maintaining organizational data standards for clinical data collection, management, and reporting.
  • Reviews and approves the draft of SDTM and ADaM metadata and conversion specifications prior to the implementation of these specifications in the clinical data warehouse.
  • Configures data transformations to provision SCHARP SDTM data tables from CRF and other data pipelines to SCHARP Programmers and Statistical Research Associates via a clinical data warehouse.
  • Provides oversight to the SCHARP SDTM and ADaM data specifications – the operating clinical data models used for reporting and deriving clinical datasets and analysis datasets, respectively.
  • Stays informed of updates to CDISC data specifications; incorporates new versions of SDTM into SCHARP SDTM and advises to others in SCHARP on CDASH and ADaM.
  • Works with study teams to lead the definition and documentation of per study SDTM metadata and conversion specifications and ensures alignment with organizational data standards.
  • Provides study teams with insight to the SCHARP ADaM data specifications.
  • Defines and documents per study clinical data transformations to SDTM+- from data collection formats such as CDASH.
  • Implements clinical data transformations of source data to SCHARP SDTM using database ETL tools. Specifies complex transformations and consults with Programmers, as needed, to implement.
  • Reviews and validates derived SCHARP SDTM and ADaM datasets using Pinnacle 21 to ensure compliance with published specifications and industry and regulatory requirements.
  • Works with IT to identify and recommend enhancements to the database ETL toolset.
  • Coordinates and may provide internal CDISC training to SCHARP and our partners as appropriate.
  • Provides supervision and leadership by training and mentoring others involved with CDISC standards, SCHARP dataset configurations, and regulatory and/or sponsor specific data requirements.

Qualifications

Minimum qualifications

  • Bachelor’s degree in Library Sciences, Informatics, Information Systems, Computer Science or other relative discipline
  • Five years of industry experience developing and implementing CDISC data standards
  • Working knowledge of CDASH, SDTM and ADaM
  • Excellent written and verbal communication skills, with the ability to work well in multi-faceted teams
  • Experience working with data documentation formats such as CSV, JSON, and XML
  • Expertise using Microsoft Excel


Preferred qualifications

  • Experience building transformation pipelines using modern ETL tools such as IBM InfoSphere DataStage, Pentaho/Kettle, SQL Server Integration Services, or other
  • Experience supervising or mentoring others
  • Experience programming with a modern procedural, declarative, or statistical programming language such as SAS, Perl, Python, Shell or SQL
  • Experience working in an environment governed by Good Clinical Practices, Good Clinical Data Management Practices, or other FDA guidelines
  • Experience with Electronic Data Capture (EDC) systems

Lead Software Development Engineer

FH Vaccine and Infectious Disease Division
Category: Information Technology
Seattle, WA, US
Job ID: 13241

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.

The Statistical Center for HIV/AIDS Research and Prevention (SCHARP) at Fred Hutch is a full service statistical and data management center focused on HIV prevention research. SCHARP has an annual budget of over $40 million, more than 180 employees and is currently managing over 40 active phase I – III clinical trials in over 150 clinical sites around the world. SCHARP is seeking a Lead Software Developer with professional experience to add to our development team.

Responsibilities

  • Lead development teams and facilitate design decisions 
  • Create and maintain technical specifications and architecture documents 
  • Implement and maintain systems within a validated software development lifecycle 
  • Participate in agile requirements gathering, design and tasking 
  • Provide operational support for existing systems 
  • Work on a project team with customers, business analysts, project management and testers 
  • Work on a development team creating and following standards that help with cross training and reducing system maintenance tails 

Qualifications

Minimum: 

  • 5+ years professional experience in software development 
  • Expertise with modern OOP programming paradigms / languages 
  • Experience with relational data modeling: conceptual and physical 
  • Defining and writing automated unit and functional tests 
  • Detail oriented including the following: 
    • Ability to understand a system of complex interactions
    • Capable of deep troubleshooting and discovering root causes of problems
    • Writes unit tests with the same care as product code
    • Has well-commented code 

  

Preferred: 

  • Java full stack web application development experience, both front-end and back-end 
  • Agile development 
  • UNIX systems 
  • PostgreSQL 
  • Javascript, Selenium 
  • Play Framework 
  • Microservice architecture 
  • Docker, Kubernetes, AWS 
  • Functional programming
  • Working in a regulated environment such as 21 CFR Part 11, Sarbanes-Oxley or HIPPA 

 

Culture: 

  • Work in an organization that strives to make the world a better place.  
  • Work with developers who enjoy crafting quality code and robust performant systems.  
  • Work in vibrant South Lake Union Seattle.  
  • Strong commitment from management to a 40 hour work week.  
  • Benefits include paid vacation, holidays, sick time, medical, dental and vision benefits as well as 403 (b) retirement plan. 

Manager, Biostatistics

FH Vaccine and Infectious Disease Division
Category: Biostatistics, Bioinformatics and Computational Biology
Seattle, WA, US
Job ID: 13947

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. The Center’s five scientific divisions collaborate to form a unique environment for conducting basic and applied science. Vaccine and Infectious Diseases Division (VIDD) works to eliminate or minimize the impact of globally significant infectious diseases. Within VIDD is the Statistical Center for HIV/AIDS Research & Prevention (SCHARP), which provides statistical support and data management to researchers worldwide in the fight against HIV/AIDS with active studies in the U.S., Africa, Latin America, Asia and Europe. Careers Start Here.


The Statistical Center for HIV/AIDS Research and Prevention (SCHARP) at Fred Hutch is seeking a Statistical Manager to provide biostatistics support, contribute to the development of policies and procedures, oversee statistical workflow/priorities for the HPTN clinical trial network, supervise Statistical Research Associates (biostatisticians) and liaise with network faculty. Responsibilities may include being a lead protocol statistician on selected protocols. 

Responsibilities

The incumbent works independently, primarily coordinating and providing statistical leadership on major scientific projects, demonstrates a high level of knowledge in statistical science or biostatistics and may specialize in a certain areas such as HIV prevention clinical trials, and directs the team of Statistical Research Associates for a clinical trial network by providing technical and organizational leadership. 

  

Responsibilities may include: 

  • Provide leadership and management to the network team of SRAs. 
  • Establish goals and timetables for projects. 
  • Supervise statistical research associates.
  • Facilitate professional growth and training.
  • Assist in the development of quality assurance procedures for on-going data collection and analysis. 
  • Provide statistical consultation for research projects.
  • Coordinate production of statistical reports.
  • Represent statistical unit at SCHARP’s organizational meetings.
  • Write statistical analysis plans. 
  • Provide statistical analysis of project data. 
  • Either write or confirm statistical considerations in protocol (sample size/power).
  • Prepare written summaries and tables of results for use in project reports, scientific papers, Data and Safety Monitoring Board, and grant applications.
  • Participate in protocol team meetings. 
  • Review protocol drafts.
  • Review case report forms. 
  • Curate and archive statistical documents. 
  • Represent project at scientific meetings.
  • Perform other responsibilities as required. 

Qualifications

  •  Master’s degree in Statistics, Biostatistics, Data Science or Analytics or a related field and minimum of 5   years of related experience.
  •  Proficiency with the statistical packages used within the department/project including SAS and R. 
  •  Strong oral and written communication skills.
  •  Demonstrated supervisory and/or management skills. 

PMO Manager

FH Vaccine and Infectious Disease Division
Category: Project Management
Seattle, WA, US
Job ID: 13683

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.

 

The Statistical Center for HIV/AIDS Research and Prevention (SCHARP) at Fred Hutch is a full service statistical and data management center focused on HIV prevention research. SCHARP has an annual budget of over $40 million, more than 180 employees and is currently managing over 40 active phase I – III clinical trials in over 150 clinical sites around the world. SCHARP is seeking a PMO Manager who will directly supervise and mentor SCHARP project management team members, including both Project Managers and Business Analysts. They will influence the use of project management and business analyst best practices, plan, coordinate resources, schedule, budget, and execute projects across SCHARP that support the clinical research. This role will also provide input into strategic issues, policy, goals, and objectives.

Responsibilities

  • Leverages PMBOK and BABOK best practices to influence team member and project activities.
  • Manage projects of a size and scope allowed by the available bandwidth of the manager role.
  • For assigned projects:
  • Works with project sponsors, business analysts and stakeholders to define project requirements, scope, risks, organization, and approach.
  • Responsible for creation and management of project artifacts including charters, change management plans, communication plans, work breakdown structures, schedules, risk, issue, and decision logs.
  • Works with resource managers to obtain resources.
  • Provides leadership and direction to the project team, in alignment with SCHARP SDLC where applicable.
  • Builds and maintains strong working relationships with team members, project sponsors and peers.
  • Provide status reporting to senior management and the project management steering committee (PMSC), project sponsors, team, and stakeholders.
  • Manages scope, schedule, and budget changes according to defined change control procedures.
  • Serves as project liaison, representing the project to other departments, affiliated individuals or institutions, and outside organizations as applicable.
  • Applies experience and knowledge in support of operational and technology goals.
  • Supervise the Project Management and Business Analyst teams, providing mentoring and coaching, performance evaluations, administrative oversight, and a lead role in the hiring process.
  • Participate as a non-voting member of the PMSC.
  • Responsible for assignment of project management and business analysis resources for approved projects and initiatives.
  • Participate in Management team meetings providing input to strategic and policy issues, goals, and objectives.
  • Performs other responsibilities as required.

Qualifications

Minimum qualifications: 

  • Master’s degree in a work-related discipline from an accredited college or university, or Bachelor’s degree plus relevant work experience.
  • PMP Certification 
  • Minimum of five years’ experience as a project manager for medium to large infrastructure and support system projects
  • Must have advanced knowledge of PMLC and SDLC best practices 
  • Solid understanding of quality principles as applied to technology projects.
  • Excellent written and verbal communication skills are essential.

  

Recommended qualifications: 

  • Knowledge of clinical trials research and data pipelines 
  • Knowledge of 21 CFR Part 11 regulations 
  • Familiar with CDISC standards 

Post-Doctoral Research Fellow

FH Vaccine and Infectious Disease Division
Category: Biostatistics, Bioinformatics and Computational Biology
Seattle, WA, US
Job ID: 14085

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first and largest cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.

 

There is an opening for a post-doctoral fellow to work on multi-modal single cell analysis and software infrastructure in the lab of Dr. Greg Finak at the Fred Hutchinson Cancer Research Center in Seattle, WA.

 

About the Lab

We are part of the RGLab, the Biostatistics, Bioinformatics, and Epidemiology program and the Vaccine and Infectious Disease Division of Fred Hutch in Seattle. We develop statistical methods and software tools for the analysis of high throughput biological data with an emphasis on immunology and vaccine research. We work with bench scientists and clinicians to understand and ultimately help develop vaccines and/or cure severe diseases such HIV, malaria, and cancer. We are a diverse group, with training in Statistics, Computer Science, Web Development, Bioengineering, Bioinformatics, and Computational Biology. Learn more about us at rglab.org and see some of our work on GitHub (github.com/RGLab).

Responsibilities

Dr. Finak is seeking a post-doctoral fellow to develop multi-modal (Ab-Seq, CITE-Seq, etc) single-cell assay data infrastructure and analysis as part a CZI Seed Network award to the Bioconductor consortium. The successful candidate will work with a motivated team to develop & implement single-cell specific data structures for storing, manipulating and interacting with multi-modal assay data such as Ab-Seq and CITE-seq, which enable simultaneous measurement of protein and RNA from the same single cell. The candidate will also work to adapt single-cell analytics methods developed in the lab (MAST https://doi.org/10.1186/s13059-015-0844-5 , FAUST

https://doi.org/10.1101/702118) to work with these data types. The candidate is expected to adhere to good software development practices (e.g. design, unit tests, documentation, code review), and participate in regular team meetings.

Qualifications

To be considered, candidates must have:

  • PhD in Bioinformatics, Computer Science, Computational biology or equivalent field.
  • R (advanced) and C++ (intermediate).
  • Unix-alike operating system environment (intermediate)
  • R package development (intermediate)
  • Bioconductor stack (advanced)
  • Software version control (e.g. git working knowledge or greater)
  • Candidate should have a strong work ethic and analytical skills, an ability to work in a team, to meet deadlines and to deliver a robust, well-tested and well-documented, quality codebase

 

Preferred Qualifications

  • Track record of contributions to open source software projects.
  • Excellent written and oral communication skills.

 

To Apply:

Please apply with your CV and a letter summarizing your research interests.

Post-Doctoral Research Fellow, Computational and Math Modeling of Cholera Transmission

FH Vaccine and Infectious Disease Division
Category: Post-Doctoral Research Fellows and Associates
Seattle, WA, US
Job ID: 13815

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first and largest cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.


Biostatistics, Bioinformatics and Epidemiology (BBE) at Fred Hutch is seeking to fill a post-doctoral position studying epidemiological transmission cholera. This is a full-time position with excellent benefits. Funding is available for up to two years. Applications will be continuously received and evaluated until the position is filled.

Responsibilities

A Post-Doctoral Research Fellow position with focus on development, refinement, and utilization of different classes of epidemiological transmission cholera models, is available in the Vaccine and Infectious Disease Institute at Fred Hutch. Applicant will be joining a dynamic multi-disciplinary group to work on optimizing vaccine allocation for cholera vaccines. This research will be used by the Global Taskforce for Cholera Control to inform and improve national cholera control plans in affected countries. Among the key objectives of the modeling work are improving the understanding of cholera transmission, informing effective public health campaigns, and guiding rational development of new vaccine interventions.  The position will require a substantial amount of programming and computation, excellent oral and writing communication skills.

Qualifications

To apply, please submit a single PDF document containing (1) cover letter including the names and contact information of three references (2) curriculum vitae.


Required qualifications:

  • PhD or equivalent degree in applied mathematics, statistics/biostatistics, infectious disease epidemiology, population biology, theoretical physics, computer science or a similarly quantitative discipline.
  • Proficiency in at least one scientific computing software (Python, Matlab, etc).
  • Excellent oral and writing communication skills

Preferred qualifications:

  • Research experience in mathematical modeling of infectious disease transmission
  • Experience with reviewing/analyzing scientific literature
  • Research experience in mathematical optimization of resources
  • Experience with statistical methods of model calibration or longitudinal data analysis
  • Peer-reviewed scientific publications

Post-Doctoral Research Fellow, Data Science

FH Vaccine and Infectious Disease Division
Category: Post-Doctoral Research Fellows and Associates
Seattle, WA, US
Job ID: 13395

Overview

 

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.

 

The Gottardo Lab is a Research Lab within the Computational Biology department at the Fred Hutchinson Cancer Research Center. We develop statistical methods and computational tools for managing and analyzing high-throughput biological data including single-cell RNA-seq, flow-cytometry, CyTOF and CITE-seq, to name a few. We then utilize these tools, in collaboration with immunologists and clinicians, to analyze high-dimensional data from pre-clinical and clinical trials in an effort to accelerate the development of new cancer immunotherapies and vaccines. Our lab participates in large collaborative efforts funded by the NIH, Gates Foundation and the CZI including the Human Immunology Project Consortium, the Human Cell Atlas, the Cancer Immunotherapy Trial Network and the Collaboration for AIDS Vaccine Discovery.

 

As a lab, we value inclusion and a diversity of backgrounds and perspectives to inform our work. We believe in supporting each other through mentorship and providing resources for professional development. Given these values, we strive to make our recruitment and promotion processes fair and transparent. Therefore, we strongly encourage all individuals with an interest in the position to apply. To learn more about our lab visit rglab.org.

Responsibilities

  • Develop statistical and computational methods for analyzing and integrating high dimensional single-cell data generated by cutting-edge technologies including single-cell RNA-seq, CITE-seq, flow cytometry and CyTOF
  • Work with immunologists and clinicians to apply these tools in the context of cancer immunotherapy and vaccine development.

Qualifications

Minimum qualifications:

  • Recent PhD degree in statistics/biostatistics, computer science, or other fields with strong quantitative training or experience
  • Strong programming skills in C/C++, R or similar languages
  • Ability to communicate effectively and work in a team-based setting


Preferred qualifications:

  • Background in Biology
  • Previous experience with genomics or immunological data analyses
  • Experience with good software development practices (e.g. design, unit tests, documentation, code review) for reproducible science

Post-Doctoral Research Fellow, Human Immunology

FH Vaccine and Infectious Disease Division
Category: Laboratory Research Sciences
Seattle, WA, US
Job ID: 13908

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.

 

The Newell Lab (publication list)was originally established in 2012 at the Singapore Immunology Network, Singapore and then moved to the Vaccine and Infectious Disease Division of the Fred Hutchinson Cancer Research Center in August 2018.

 

A major goal of lab is to exploit T cell antigen-specificity to gain clinically relevant insights about human immunity in the context of cancer and infectious disease. This is achieved through leveraging expertise in the use of highly-multiplexed peptide-MHC tetramer staining in conjunction with mass cytometry or single-cell sequencing to deeply profile human antigen-specific T cells. In addition, novel experimental and computational approaches are being developed that allow for improved examination of T cell phenotypes, function, antigen specificity, as well as T cell receptor repertoire. Although the lab focuses mostly on studying the roles of T cells in human health and disease, we also participate in many projects related to other cell types and mouse tumor systems are also employed.

 

Our Lab is seeking outstanding and open-minded Postdoctoral Fellows to work on developing and implementing cutting edge analysis to investigate the roles of T cells in various models of cancer and infectious disease.

Responsibilities

  • Learning nuances of implementation of mass cytometry and single-cell sequencing based approaches for the analysis of relevant cellular samples
  • Application of highly multiplexed peptide-MHC multimer analysis using mass cytometry
  • Experimental design, planning and coordination with collaborators
  • Initiate and carry out scientific projects, under the supervision of Evan Newell
  • Develop new ideas for projects or approaches based on immunological interest and knowledge of the literature
  • Conduct and publish research in appropriate journals.

Qualifications

  • A doctoral degree in immunology, biochemistry, life sciences or related fields
  • Experience with flow cytometry and/or single cell sequencing required (mass cytometry experience preferred but not required)
  • An interest in T cell immunology
  • Computer programming or bioinformatics skills would be very advantageous but not required
  • Experience with protein expression and purification would also be advantageous
  • An ability to learn new techniques and troubleshoot assays
  • Good team player, independent, self-driven with good interpersonal skills

Post-Doctoral Research Fellow- B Cell Genetic Engineering

FH Vaccine and Infectious Disease Division
Category: Post-Doctoral Research Fellows and Associates
Seattle, WA, US
Job ID: 13726

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.

Responsibilities

The Taylor lab at the Vaccine and Infectious Disease Research Division is recruiting postdoctoral fellows to work on a project involving the analysis or genetic engineering of murine or human B cells. The candidate must be responsible, organized, and self-motivated, and able to efficiently manage time and experiments.

Qualifications

A PhD in immunology, genetic engineering, microbiology, cell biology, or a related field is required. A cover letter or brief research statement is required.

 

Preference will be given to candidates with extensive experience in molecular biology and cutting-edge genetic engineering techniques. The candidate must show initiative, the willingness to take up new skills and responsibilities, and be a team player. Must be willing to work with human cells, murine models and biohazardous/infectious agents (BSL2+) under carefully controlled conditions. Excellent attention to detail and the ability to work independently are essential to success in this position, as are good communication and organizational skills. Salary will be commensurate with (appropriate) experience.

Post-Doctoral Research Fellow- Viral Immunology

FH Vaccine and Infectious Disease Division
Category: Post-Doctoral Research Fellows and Associates
Seattle, WA, US
Job ID: 13902

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.

Responsibilities

The Lund lab in the Vaccine and Infectious Disease Research Division is recruiting a postdoctoral fellow to work on human mucosal immunity projects. Specifically, projects involve investigating how exposure to and infection with various viruses such as HIV and HSV affect mucosal and peripheral immune activation, as well as defining unique features of human tissue lymphocytes compared to circulating lymhocytes. The candidate must be proficient in high-parameter flow cytometry and have extensive experience in experimental immunology. In addition, the candidate must be responsible, organized, and self-motivated, and able to efficiently manage time and experiments.

 

A statement of research interests and/or a cover letter are required. Salary will be commensurate with (appropriate) experience.

Qualifications

  • A PhD in immunology, microbiology, cell biology, or a related field is required
  • Candidates must have experience with flow cytometry, and be willing to work with microbial agents and/or infected tissues
  • The candidate must show initiative, the willingness to take up new skills and responsibilities, and be a team player
  • Must be willing to work with biohazardous/infectious agents (BSL2+) under carefully controlled conditions
  • Excellent attention to detail and the ability to work independently are essential to success in this position, as are good communication and organizational skills

Post-Doctoral Research Fellow-Jerome Lab

FH Vaccine and Infectious Disease Division
Category: Post-Doctoral Research Fellows and Associates
Seattle, WA, US
Job ID: 14209

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.

Responsibilities

The Jerome Laboratory in the Vaccine and Infectious Disease Division at the Fred Hutchinson Cancer Research Center is recruiting a Post-Doctoral Fellow to conduct laboratory bench research to evaluate HIV cure strategies, gene therapy, and methods to assess the latent cell reservoir.  Approaches to be used include genome editing, cell culture, multi-color flow cytometry, biochemical analysis, next-generation sequencing, and others. In addition to performing bench experiments, the individual is expected to help write manuscripts, grant proposals and present research at scientific meetings.

Qualifications

  • Seeking a candidate with a Ph.D. in the field of Immunology/Virology. 
  • Knowledge of molecular biology, primary cell/HIV culture preferred.
  • Must have viral work experience.
  • Experience with multi-color flow cytometry.
  • Gene editing experience preferred.
  • The candidate should be a self-starter and be able to work independently in a team environment. 
  • Strong analytical, writing, communication, and problem solving skills are desired. 

A statement of research interests and/or a cover letter are required. Salary will be commensurate with (appropriate) experience.

Post-Doctoral Research Fellow: Antibody-mediated protection of EBV

FH Vaccine and Infectious Disease Division
Category: Post-Doctoral Research Fellows and Associates
Seattle, WA, US
Job ID: 13900

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.

 

The McGuire Lab is seeking outstanding post-doctoral fellows to work on a project involving the validating and testing of antibodies to prevent infection with Epstein-Barr virus; an important cancer associated pathogen.

Responsibilities

The successful candidate will design and execute antibody-mediated protection studies in in small animals and non-human primates to evaluate the efficacy of antibodies, both passively delivered and vaccine-elicited, to prevent infection and/or EBV-associated cancers. The incumbent will perform endpoint analyses including serum antibody neutralizing titers, assays for detecting viral infection, and analyzing immune responses to treatment/vaccination.

Qualifications

Required:

  • PhD in immunology, microbiology, cell biology, or a related field
  • Experience conducting in vivo studies in murine models, preferably immune analysis
  • The candidate should have a strong virology background
  • Must be willing to work flexible hours as needed
  • Be independent, show initiative, willingness to take up new skills and responsibilities, and be a team player
  • Excellent attention to detail, good communication, and organizational skills are essential to success in this position
  • The candidate must be self-motivated, able to multitask and to work within a very collaborative environment.

Please submit a cover letter with your application discussing your interest in the role and future career goals.

Post-Doctoral Research Fellow: HIV-1 Vaccine Development

FH Vaccine and Infectious Disease Division
Category: Post-Doctoral Research Fellows and Associates
Seattle, WA, US
Job ID: 13899

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.

 

The McGuire Lab is seeking outstanding postdoctoral fellows to work on a project involving the validating and testing of novel vaccine candidates to elicit broadly neutralizing antibodies against HIV-1.

Responsibilities

The successful candidate will design and execute prime-boost immunization regimens in a humanized murine model which will serve as a surrogate for human vaccine trials. The candidate will perform endpoint analyses including antigen-specific B cell sorting and serum antibody binding and neutralization assays to gain a high-resolution understanding of the immune response to immunization. To complement this analysis the candidate will perform single B cell sorting of human PBMC samples ascertain the identity of antigen-reactive naïve B cells. 

Qualifications

Required:

  • PhD in immunology, microbiology, cell biology, or a related field
  • Experience with conducting in vivo studies in murine models, preferably immune analysis 
  • Experience with multi-color Flow Cytometry preferred
  • Strong molecular biology background
  • Willing to work flexible hours as needed
  • Must be independent, show initiative, willingness to take up new skills and responsibilities, and be a team player
  • Excellent attention, as well as good communication and organizational skills are essential to success in this position
  • Must be self-motivated, able to multitask and to work within a very collaborative environment

Preferred:

  • Expertise in B cell immunology is highly desirable

Please submit a cover letter with your application discussing your interest in the role and future career goals.

Post-Doctoral Research Fellow: Statistical and Computational Evaluation of Infectious Disease Vaccine Interventions

FH Vaccine and Infectious Disease Division
Category: Post-Doctoral Research Fellows and Associates
Seattle, WA, US
Job ID: 13493

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.


Biostatistics, Bioinformatics and Epidemiology (BBE) at Fred Hutch is recruiting for a Post-Doctoral Position for Statistical and Epidemiologic Methods for Evaluating Vaccines. The postdoc will be supervised by Professor M. Elizabeth Halloran and based at the Fred Hutchinson Research Center in Seattle, WA. The postdoc will be joining a national and international network of researchers who have worked together over many years. The Vaccine and Infectious Disease Division of Fred Hutch has a large group of faculty working on statistical and epidemiologic methods for evaluating vaccines.


Two years of funding are available, with a negotiable start date of early fall 2019.

Responsibilities

We are seeking a postdoctoral fellow to work in developing novel statistical and epidemiologic methods for evaluating interventions in populations, in particular vaccines, in infectious diseases. Some of the research will focus on study designs for emerging infectious diseases, such as Zika, Ebola, pandemic influenza, and others. Some of the research will focus on other endemic or re-emerging infectious diseases, such as dengue, influenza, pertussis or rotavirus, but not HIV.


The postdoc may be expected to work with and develop state-of-the-art computational methods and phylogenetic techniques. 

Qualifications

To apply, please submit a single PDF document containing (1) cover letter including the names and contact information of three references (2) curriculum vitae (3) at least two representative papers.

 

Required qualifications:

  • The postdoc needs to have a PhD or other doctoral level degree in statistics, biostatistics, computer science, quantitative epidemiology, or some related quantitative field, granted in the past five years
  • Excellent communication skills, both verbal and written, are required

Preferred qualifications:

  • Experience with applications in infectious diseases is desired
  • Interest in learning or previous experience with phylodynamic methods is also desirable
  • A knowledge and experience with methods of causal inference would be helpful
  • A preference will be for individuals planning to develop their own independent research after the postdoc

Program Manager

FH Vaccine and Infectious Disease Division
Category: Clinical Research Support Services
Seattle, WA, US
Job ID: 14222

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.

 

The Statistical Center for HIV/AIDS Research and Prevention (SCHARP) at Fred Hutch is a full service statistical and data management center focused on HIV prevention research. SCHARP has an annual budget of over $40 million, more than 180 employees and is currently managing over 40 active phase I – III clinical trials in over 150 clinical sites around the world. SCHARP's Programming Unit is seeking a Program Manager who reports to the Senior Manager of Programming and provides program management of technical and strategical operations of the programming Unit. The individual will be a self-starter, highly engaged, own challenges and opportunities from end-to-end by bringing structure and efficiency to processes and projects in the programming group. The individual will collaborate directly with stakeholders internal and external to SCHARP, fostering communication and partnerships to provide programming solutions. The Programming Unit Program Manager executes the report/project/process plans, proactively mitigates the risks, and manages report/data intake portfolio from inception to production launch and post production support.

Responsibilities

In this role, the individual will be working cross-functionally to align goals between network partners and programming teams, focusing on the larger business and technology picture which includes stakeholders experience, programmers know-how, process improvements, programming opportunities and/or problems to be solved.

 

The Programming Unit Program Manager will be in charge of defining and delivering technical, data-driven reports/solutions/projects by building a bridge between a large network of technical and non-technical stakeholders in the organization with the Programming team. Program Manager understands the operational workflows, clinical areas of concern, security, privacy, regulatory compliance before proposing and assessing solution. They will be responsible for effective communication strategies, technical requirements management, priority management, resource and schedule management, test and release management.

 

Responsibilities may include:

  • Building and maintaining strong working relationships by serving as a primary SCHARP operational liaison across all stakeholder groups (ADs, Regulatory Affairs, Safety, CTMs, CDMs, Programmers) to better understand the business goals, needs, requirements and then translating them into detailed technical requirements.
  • Lead the team of Report Analytics by working with cross-functional team leadership to establish goals and milestones that align with team requirements, raise risks and dependencies, and drive towards cross-team collaborative solutions.
  • Understand the strategic vision for both Senior Manager and other functional  managers and use this information to create a technical/programming roadmap and corresponding project scopes.
  • Define requirements and source opportunities for improvement, gather stakeholders to refine solutions in both programming and process and shepherd implementation and instrumentation to deliver and measure the output.
  • Subject matter expert for all aspect of data reporting operations, understanding the end-to-end flow of data – from capture and storage to reporting schema and end-user dashboards.
  • Recognizing and tracking dependencies, identifying roadblocks and helping clear them, communicating status and aligning across teams from inception to release, and helping find creative solutions to provide core value.
  • Able to establish goals and set clear expectations, prioritize activities, and follow through to completion. Also, identify, track and actively manage dependencies, working closely with the Network Portfolio Managers on any cross-team dependencies to anticipate, track and mitigate program and project-related issues and risks.
  • Managing day-to-day communication and coordination of cross-functional teams including technical/non-technical, clinical, and other executive stakeholders ensuring clarity, focus and high-quality. 
  • Locate and define process improvement opportunities - to drive standardization efforts and solve for root cause issues with a focus on increasing organization transparency and efficiency.
  • Identify, understand and map source data systems (EDC RAVE) to the data warehouse/mart models (Delphi) and then transform data into actionable reports.
  • Develop processes/procedures for capturing, implementing and maintaining business rules and metadata. Also, processes for platform optimization of performance, quality, and business continuity.

Qualifications

Required

  • Bachelor’s degree in Business or a scientific, technical, or health-related field
  • 4 years of experience as a business analyst or related experience (e.g. data analytics)
  • 3+ years of Business Intelligence knowledge and delivery experience and understanding of BI technology stack (SQL Server, Tableau, Power BI, Business Objects, etc.)
  • 3+ years Experience with SAS, R and RDBMS technologies
  • Strong analytics knowledge
  • Knowledge of principles for effective visual display of quantitative data
  • Experience in programming, system, and/or database documentation and validation
  • Ability to collect, organize, analyze, and disseminate significant amounts of information with attention to detail and accuracy
  • Ability to synthesize complex elements into crisp and robust requirements for audiences of variable technical levels
  • Ability to dive deep into data, existing processes, people and systems in order to invent, simplify, and improve inefficient or unnecessarily complex processes
  • Demonstrated ability to communicate effectively the programming issues with non-technical staff in a matrix management environment
  • Demonstrated ability to meet tight deadlines while managing multiple competing tasks in a fast-paced environment
  • Demonstrated ability to multi-task and appropriately prioritize work assignments
  • Strong interpersonal skills including written and verbal communication skills necessary to build effective working relationships and positively influence decision making

 

Preferred

  • Master’s degree in Business, or a scientific, technical, or health-related field
  • Project Management Professional (PMP) Certification
  • Knowledge of regulatory requirements for clinical trials and reporting
  • Knowledge of relational databases and database management experience
  • Knowledge of and experience in programming for scientific research
  • Previous clinical trials and analysis experience

Project Coordinator II

FH Vaccine and Infectious Disease Division
Category: Administrative Support
Seattle, WA, US
Job ID: 14168

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.


The Cancer Immunotherapy Trials Network (CITN) is a National Cancer Institute (NCI) sponsored network initiated to stimulate the conduct of early (Phase I and Phase II) clinical trials in the area of cancer immunotherapy. The network is coordinated through a Central Operations and Statistical Center (COSC), which is housed at Fred Hutchinson Cancer Research Center. The Network is supported by an NCI contract, and a commitment of substantial NCI services, augmented by Fred Hutchinson Cancer Research Center (Fred Hutch) institutional funds.


We are seeking an energetic individual with substantial background in clinical administration for the position of Project Coordinator II. The Project Coordinator will report directly to the CITN Administrative Director. The Project Coordinator will be responsible for working closely with CITN COSC staff to manage all aspects of administration of an international network with protocol being conducted at Network clinical sites in addition to helping with a variety of operational tasks.


Coordinates research and administrative activities in support of a project or study, developing policies, procedures, research instruments and administrative materials, carrying-out moderately complex research assignments and assisting in study implementation.

Responsibilities

The incumbent works under the direction of the Program Administrator or Principal Investigator, referring project/study issues on and/or soliciting guidance as necessary. Special skills and knowledge are applied in coordinating research and administrative activities and in carrying-out moderately complex research assignments.

 

Perform some or all of the following responsibilities:

  • Coordinate all administrative activities of the clinical networks and Principal Investigator ensuring all projects are completed according to project/study timelines
  • Set project goals and timelines and communicate with clinical sites, ensuring that research and study administrative activities are completed as required to maintain regulatory and protocol compliance
  • Assist in the development of project/study policies and procedures. Administer policies and procedures according to protocol, IRB, grant/contract and Center specifications
  • Distribute and track approved protocols, amendments and regulatory documents for all participating clinical sites
  • Manage multiple rosters of all study personnel at participating clinical sites
  • Provide and track training materials to all staff participating in each clinical protocol
  • Serve as Coordinating Center liaison, representing the Coordinating Center to other Center departments, external funding sources, affiliated individuals or institutions and outside organizations.
  • Support departmental Clinical Trial Managers over the course of the clinical trial as it relates to protocol implementation, training and maintenance of regulatory task
  • Track study data and compile metric data reports.
  • Coordinate the submission of study results, articles, and manuscripts for publication, ensuring that all materials are compiled, formatted and submitted in accordance with requirements and that deadlines are met.
  • Liaise with web developer to maintain current network websites
  • Assist Coordinating Center with administrative tasks, i.e., calendaring, meetings, reimbursements
  • Produce special and recurring reports
  • Perform other responsibilities as required

Qualifications

  • BA/BS in related field required. MA/MS desired
  • Minimum of one year post-master's or three years post-bachelor's project coordination experience
  • Excellent written and verbal communication skills

Python Programmer

FH Vaccine and Infectious Disease Division
Category: Biostatistics, Bioinformatics and Computational Biology
Seattle, WA, US
Job ID: 12999

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.


The Statistical Center for HIV/AIDS Research and Prevention (SCHARP) at Fred Hutch is a full service statistical and data management center focused on HIV prevention research. SCHARP has an annual budget of over $40 million, more than 180 employees and is currently managing over 40 active phase I – III clinical trials in over 150 clinical sites around the world. SCHARP is seeking a Lab Programmer II. Under general supervision of the Lab Programming Supervisor or Manager, the Lab Programmer provides programming support for Lab data management, reporting, and analysis needs of SCHARP. The Lab Programmer works in a team environment to support the overall mission of SCHARP. Core to the role is communicating effectively with team members and being responsive to the needs of various constituents inside and outside of the Division.

Responsibilities

The Lab Programmer will provide programming support for Lab Data Management services that include work with SCHARP analysis teams, external labs, and Network partners. Lab Data Management services focus on processing Assay and Specimen Data. The Lab Programmer will assist the team in building, maintaining, processing, and troubleshooting all aspects of our production assay data pipelines. The Lab programmer will also support and monitor specimen data reconciliation as well as take on team projects to improve team processes and code. Responsibilities may include:

 

  • Gather and document requirements for developing or modifying existing programs and systems and defining file specifications for data transfer and necessary edit checks and transformations to meet user needs.
  • Create, setup, test, and maintain Assay data pipelines for analysis.
  • Create, setup, test, and maintain Specimen data reconciliation process.
  • Work with SCHARP and external lab staff to resolve discrepancies between protocol expectations, case report form data, assay data, and specimen data.
  • Test and de-bug programs and maintain version control on production programs and scripts.
  • Create, test, document, and maintain SCHARP quality control checks.
  • Create, test, document, and maintain ad hoc, standard, and study-specific reports.
  • Support development of new or updates to work instructions (WIs) and standardization of processes (SOPs).
  • Train external users on data upload procedures and data submission best practices.
  • Ability to troubleshoot and resolve lab programming-related issues.
  • Take initiative and lead team projects in best practices or process improvements.
  • Apply best programming practices and collaborate with team members.
  • Ability to work under pressure and juggle multiple projects.
  • Perform other duties as required or assigned.

Qualifications

Required

  • Bachelor’s degree in Computer Science or similar degree in a scientific, technical, or health-related field or additional programming training, skill, or experience.
  • Two years’ experience in Python, SAS or any object-oriented programming language on Linux/Unix platform.
  • Ability to work independently and communicate effectively as part of a project team.
  • Ability to learn new programming skills as needed.
     

Preferred

  • Basic SAS experience.
  • Basic JavaScript experience.
  • Basic Database Design and SQL experience.
  • Basic SVN experience or any major source control application experience.
  • Basic JIRA experience or any major ticket tracking application.
  • Knowledge of and experience in programming support of clinical trials, statistical programming, or other scientific research programming support.
  • Experience reading, parsing and transforming lab instrument data files programmatically.
  • Experience reading, parsing and creating Excel files programmatically.
  • Knowledge of laboratory procedures for assays, and work with laboratories to receive assay results.
  • Understanding of computerized systems validation.

QA Associate I, HVTU Lab Operations

FH Vaccine and Infectious Disease Division
Category: Laboratory Research Sciences
Seattle, WA, US
Job ID: 12391

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.

 

The HIV Vaccine Trials Network (HVTN) Laboratory Center is part of an international collaboration of scientists and educators searching for effective and safe vaccines. The HVTN’s mission is to facilitate the process of testing preventive vaccines against HIV/AIDS and related infectious diseases. The organization conducts all phases of clinical trials from evaluating experimental vaccines for safety and the ability to stimulate immune responses through to testing vaccine efficacy. The Laboratory Center is responsible for carrying out the scientific agenda of the HVTN by conducting laboratory-based studies to evaluate the immunogenicity of investigational vaccines.

Responsibilities

The focus of responsibilities for the QA Associate I is to manage, oversee, coordinate and facilitate site specimen processing and clinical testing lab projects and programs for the HVTU Laboratory Operations Division.

 

Responsibilities can be broken out by the following:

 

HVTN Lab Site Operations Support

  • Oversee and coordinate up to 20 assigned site labs for HVTN and client protocol preparation; includes provision of site training, ensuring appropriate supplies on site, developing and communicating protocol-related lab practices, determining site equipment needs, and monitoring Good Clinical Laboratory Practice compliance.
  • Provide site lab support, training and protocol lab practice reviews through regular site visits, conference calls or other appropriate media; adapt communication styles based on targeted audience and topic.
  • Assist site labs with implementation of their tailored Quality Assurance plans, including but not limited to the writing and use of laboratory SOPs, establishment of equipment maintenance programs, and proper data and specimen management.
  • Provide support, investigative consultation, and monitor effective resolution for site laboratory testing, protocol issues and applicable quality system problems.
  • Review and analyze site labs’ workload, performance and adherence to approved Quality Assurance Program. 
  • Develop and implement site training programs and tools for new specimen processing techniques that include quality assurance practices.
  • Provide LDMS (centralized laboratory data management system) support to sites; provide program input to the developer, Frontier Science.
  • Manage site supply program including resourcing new supplies and vendors, monitoring site delivery system and oversight of invoices.
  • Provide input and support to HVTN and client protocol teams regarding local lab testing/methodologies, processing, storage and shipping of specimens.

HVTU Support

  • Provide oversight for Peripheral Blood Mononuclear Cell (PBMC)/serum/plasma processing and cryopreservation training and certification program.
  • Provide PBMC External Quality Control program support including analysis, interpretation and reporting to sites.  Review adequacy of site response on EQC reports.
  • Provide input and support to for HIV/AIDS Network Coordination (HANC) lab programs, including the Lab Focus Group.
  • Communicate as needed with Division of AIDS or DAIDs contractors.
  • Coordinate, participate and support the efforts of the HVTN Laboratory Program and perform additional activities as necessary.

Qualifications

Minimum qualifications

  • B.A./B.S. required in a medical science field
  • Minimum 5 years of experience in clinical safety laboratory
  • Experience in Good Clinical Laboratory Practices (GCLP), clinical laboratory quality assurance
  • Demonstrated experience in clinical safety laboratory management

 

Preferred qualifications

  • At least 5 years of experience as a medical technologist preferred
  • At least 1 year of experience in quality assurance preferred
  • Understanding of HIV diagnostics testing preferred
  • Demonstrated experience with PBMC (peripheral blood mononuclear cell) processing and storage and clinical trials preferred
  • Computer skills – including Microsoft Word, Excel, PowerPoint and other laboratory-specific programs
  • Ability to work in a team
  • Good numeracy, literacy and organizational skills
  • Good interpersonal and time management skills
  • Willingness to be flexible in working hours, be willing to travel as needed, and work some evenings and weekends.

QA Associate II- Vaccine Clinical Trials

FH Vaccine and Infectious Disease Division
Category: Quality
Seattle, WA, US
Job ID: 13039

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.

 

The HIV Vaccine Trials Network (HVTN) Laboratory Program is part of an international collaboration of scientists and educators searching for an effective and safe HIV vaccine. The HVTN’s mission is to facilitate the process of testing preventive vaccines against HIV/AIDS. The organization conducts all phases of clinical trials from evaluating experimental vaccines for safety and the ability to stimulate immune responses to testing vaccine efficacy. The Laboratory Program is responsible for carrying out the scientific agenda of the HVTN in determining by laboratory based studies which vaccine regimens should be advanced for efficacy trials and show promise for licensure. This effort includes leading a number of working groups, committees, specimen repository oversight, assay performance and quality assurance.

Responsibilities

Under the direction of the HVTN Associate Director for Laboratory Operations and the HVTN QA/QC Project Manager, the QA/QC (Quality Assurance & Quality Control) Associate will be responsible for participating in the development, implementation and maintenance of quality assurance systems and activities related to all aspects the Seattle HVTN Immunological Endpoint Assay and Specimen Processing Laboratories. This will include but is not limited to the duties described below.

  • Conduct laboratory audits and informal inspections to ascertain that all activities conform to Good Clinical Laboratory Practices (GCLP) standards.
  • Coordinate with the laboratory manager and related stakeholders to describe or determine the scope, objective(s), and scheduling of internal and external (e.g., study sponsor) audits.
  • Perform periodic internal audits
  • Formally document audit findings and report to HVTN Laboratory Program Director.
  • Facilitate compliance issue resolutions and incident management with laboratory managers and staff, as appropriate. Provide recommendations, communicate status of action resolution, and bring to management issues that require attention; track corrective actions for effectiveness.
  • Maintain electronic QA systems (e.g. document control).
  • Audit final study reports to ascertain that the report reflects the raw data of the study.
  • Monitor and maintain archives of pertinent documents for their adherence to GCLP principles.
  • Assess clarity, adequacy, and GCLP-compliance of new and revised SOPs. Maintain document control and historical archive of SOPs.
  • Obtain documented commitments for corrective actions and associated follow up to verify implementation of any such measures.
  • Facilitate internal and external proficiency/quality assurance testing/evaluation.
  • Host external regulatory inspections and audits.

 

In addition, the QA/QC Associate will work collaboratively with the central HVTN Quality Assurance Program. This includes interacting with QA mangers at network laboratories to help ensure compliance with HVTN procedures and DAIDS GCLP guidelines. Central QA activities will include but are not limited to:

  • Collaborate in the development, implementation, control and distribution of Standard Operating Procedures (SOPs).
  • Support of quality assessment and improvement activities for the Network; provide consultative services as appropriate.

Qualifications

  • BS or MS degree in an appropriate scientific field. Membership/certification in SQA (Society for Quality Assurance) strongly preferred.
  • Familiarity with regulatory requirements for laboratory-based immunogenicity studies
  • Experience working in a GCLP, GLP and/or GMP regulated setting
  • Familiarity with cellular immune monitoring techniques preferred
  • Experience in immune monitoring of vaccine clinical trials or vaccine development preferred.

R Statistical Programmer II

FH Vaccine and Infectious Disease Division
Category: Biostatistics, Bioinformatics and Computational Biology
Seattle, WA, US
Job ID: 13940

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. The Center’s five scientific divisions collaborate to form a unique environment for conducting basic and applied science. Vaccine and Infectious Diseases Division (VIDD) works to eliminate or minimize the impact of globally significant infectious diseases. Within VIDD is the Statistical Center for HIV/AIDS Research & Prevention (SCHARP), which provides statistical support and data management to researchers worldwide in the fight against HIV/AIDS with active studies in the U.S., Africa, Latin America, Asia and Europe. Careers Start Here.


The Statistical Center for HIV/AIDS Research and Prevention (SCHARP) at Fred Hutch is a full service statistical and data management center focused on HIV prevention research. SCHARP has an annual budget of over $40 million, more than 180 employees and is currently managing over 40 active phase I – III clinical trials in over 150 clinical sites around the world. SCHARP is seeking a Statistical Programmer II.

 

Under general supervision, the Statistical Programmer provides statistical programming expertise within SCHARP by coordinating with statisticians to write efficient, re-usable, and easily maintainable code that access, analyze and report data descriptives and analyses. The incumbent primarily uses R; additional statistical and analytical software programs are used as needed. Core to the role is the ability to communicate effectively, work collaboratively with colleagues and be responsive to the needs of both internal and external customers within an environment of mutual cooperation and respect.

Responsibilities

Responsibilities will include a subset of the following, based on network(s) supported:

  • Develop scripts for wrangling / data transformation and standardizing assay datasets
  • Generate, document, and maintain analysis datasets
  • Gather and document requirements for developing or modifying existing programs and systems
  • Define and edit analysis dataset specifications
  • Create ad hoc, standard and study-specific reports (e.g. Assay QC)
  • Test and de-bug programs and maintain version control on production programs and scripts
  • Support development of and updates to work instructions (WIs) and standardization of processes
  • Maintain automation of routine analysis data and reporting tasks
  • Contribute to good programming practices, and cross-group programming initiatives and code libraries
  • Work with clinical programmers, labs, statisticians, and other statistical programmers to resolve data quality, processing, and analysis issues

Qualifications

Required

  • Bachelor’s degree in Computer Science or a scientific, technical, or health-related field
  • Two years of experience as an R programmer on PC/Unix platform; Preferred experience programming in support of clinical trials, statistical programming in a clinical research setting or other health research programming support; experience using version control tools (e.g. git or svn)
  • Demonstrated ability to communicate effectively in a matrix management environment as a member of several project teams
  • Demonstrated ability to multi-task and appropriately prioritize work assignments
  • Experience in data wrangling / transformation, preferably within a health-related field
  • Knowledge of and experience with statistical analyses
  • Reporting and R package development abilities

 

Preferred

  • Knowledge of biological assay data
  • Advanced R programming skills
  • Ability to use Perl or other scripting languages for text manipulation and automated job control
  • Knowledge of both SAS and R (including graphics experience) and other programming languages
  • Knowledge of CDISC standards (SDTM and ADaM)
  • Knowledge of and experience with biostatistics or statistical analyses in a clinical trials setting

R Statistical Programmer III

FH Vaccine and Infectious Disease Division
Category: Biostatistics, Bioinformatics and Computational Biology
Seattle, WA, US
Job ID: 13965

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. The Center’s five scientific divisions collaborate to form a unique environment for conducting basic and applied science. Vaccine and Infectious Diseases Division (VIDD) works to eliminate or minimize the impact of globally significant infectious diseases. Within VIDD is the Statistical Center for HIV/AIDS Research & Prevention (SCHARP), which provides statistical support and data management to researchers worldwide in the fight against HIV/AIDS with active studies in the U.S., Africa, Latin America, Asia and Europe. Careers Start Here.


The Statistical Center for HIV/AIDS Research and Prevention (SCHARP) at Fred Hutch is a full service statistical and data management center focused on HIV prevention research. SCHARP has an annual budget of over $40 million, more than 180 employees and is currently managing over 40 active phase I – III clinical trials in over 150 clinical sites around the world. SCHARP is seeking a Statistical Programmer III.

 

With guidance, the Senior Statistical Programmer provides statistical programming expertise within SCHARP by coordinating with statisticians to write efficient, re-usable, and easily maintainable code that access, analyze and report data descriptives and analyses. The incumbent primarily uses R; additional statistical and analytical software programs are used as needed. Core to the role is the ability to communicate effectively, work collaboratively with colleagues and be responsive to the needs of both internal and external customers within an environment of mutual cooperation and respect. The Senior Statistical Programmer shows independence in management of workload and production of quality output, as well as technical expertise that contributes to the programmatic infrastructure of the Statistical Programming group.

Responsibilities

Responsibilities will include a subset of the following, based on network(s) supported:

  • Develop scripts for wrangling / data transformation and standardizing assay datasets
  • Generate, document, and maintain analysis datasets
  • Gather and document requirements for developing or modifying existing programs and systems
  • Define and edit analysis dataset specifications
  • Create ad hoc, standard and study-specific reports (e.g. Assay QC); may perform cross-study reporting
  • Test and de-bug programs and maintain version control on production programs and scripts
  • Design and develop new work instructions (WIs) and updates to existing
  • May coordinate efforts to standardize WIs or processes across studies
  • Develop and maintain automation of routine analysis data and reporting tasks
  • Contribute to good programming practices, and cross-group programming initiatives and code libraries
  • Work with clinical programmers, labs, statisticians, and other statistical programmers to resolve data quality, processing, and analysis issues
  • Contribute to mentoring and training of junior Statistical Programmers and may supervise as needed

Qualifications

Required

  • Bachelor’s degree in Computer Science or a scientific, technical, or health-related field
  • At least four years of experience as an R programmer on PC/Unix platform; Preferred experience programming in support of clinical trials, statistical programming in a clinical research setting or other health research programming support; experience using version control tools (e.g. git or svn)
  • Demonstrated ability to communicate effectively in a matrix management environment as a member of several project teams
  • Demonstrated ability to multi-task and appropriately prioritize work assignments
  • Experience in data wrangling /transformation within a health-related field
  • Knowledge of and experience with biostatistics or statistical analyses in a clinical trials setting
  • Advanced R programming skills
  • Strong reporting and R package development abilities
  • Knowledge of R (including graphics experience) and other programming languages
  • Ability to use Perl or other scripting languages for text manipulation and automated job control

 

Preferred

  • Graduate degree in computer science or a scientific, technical, or health-related field
  • Knowledge of CDISC standards (SDTM and ADaM)
  • Knowledge of laboratory and biological assay data

Regulatory Coordinator II- Clinical Trials

FH Vaccine and Infectious Disease Division
Category: Clinical Research Support Services
Seattle, WA, US
Job ID: 14184

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.


The Cancer Immunotherapy Trials Network is a National Cancer Institute (NCI) sponsored network tasked to stimulate the conduct of early Phase I and Phase II clinical trials in the area of cancer immunotherapy. The goals are to establish a productive network of leading investigators and institutions to implement early phase cancer immunotherapy trials, design and conduct novel biologically dictated early phase trials using agents and combinations of agents to demonstrate proof-of-concept essential to proceed to Phase III pivotal trials, and provide high quality immunogenicity and biomarker data that elucidate mechanisms of response.


The network is coordinated through a Central Operations and Statistical Center (COSC), which is housed at Fred Hutchinson Cancer Research Center. The Network is supported by an NCI grant and a commitment of substantial NCI services augmented by Fred Hutchinson Cancer Research Center institutional funds as well as industry and foundation funding.


We are seeking an energetic individual with a background in clinical research for the position of Regulatory Affairs Coordinator.

Responsibilities

The incumbent works with the Senior Regulatory Affairs Associate to ensure regulatory compliance within the CITN COSC and affiliate network and at participating clinical research sites. Job duties include:

  • Serve as regulatory support liaison for interdepartmental and external agencies including, but not limited to Cancer Treatment Evaluation Program (CTEP), Office for Human Research Protections (OHRP), Regulatory Affairs Branch (RAB), Food and Drug Administration (FDA), the Fred Hutchinson Cancer Research Center’s Institutional Review Office, NCI Central IRB, and participating CITN site IRBs
  • In conjunction with Cancer Immunotherapy Trials Network (CITN) Sr. Regulatory Affairs Associate and Clinical Trial Managers, facilitate and track trial protocols through all applicable review and approval processes including, but not limited to CTEP, FDA, IRBs, RAB, and in-country agencies
  • Assist in ensuring that participating CITN research sites have complied with all applicable regulatory requirements of the site registration process.
  • Assists the Sr. Regulatory Affairs Associate in regulatory oversight on safety reporting for the CITN and CITN affiliate network
  • Assist in compiling materials needed for investigational new drug (IND) submissions, IND safety reports and annual reports as required
  • Contribute to the design, development and implementation of SOPs that ensures the CITN COSC conducts its regulatory activities in accordance with FDA/ICH regulations and guidance documents
  • Assist in preparing and submitting regulatory documents
  • Perform document filing and retrieval as directed
  • Contribute to departmental process improvements which impact Regulatory Affairs
  • Assist the Sr. Regulatory Affairs Associate in monitoring, interpreting and validating current and changing regulatory legislation and instructional polices, and ensure new regulations or changes to existing regulations are communicated throughout the CITN COSC sharing potential impacts these changes may have on ongoing protocols
  • Assist the Sr. Regulatory Affairs Associate in managing sites who utilize the Fred Hutch IRB as the IRB of Record
  • Assist the Sr. Regulatory Affairs Associate in providing review of non-lead IRB sites consent forms and other applicable regulatory documents
  • Coordinate with others, as appropriate, to resolve highly complex or extraordinary regulatory problems that may arise seeking assistance from appropriate internal and external resources
  • Work to develop and acquire required regulatory skills and knowledge with guidance from Sr. Regulatory Affairs Associate
  • Identify potential regulatory risks to the operational plans of the CITN COSC, and propose options to mitigate risks
  • Assist in monitoring government websites for misconduct by investigators in clinical trials
  • Additional and incidental duties related to the primary job duties described above may be required for successful execution of job performance.

Qualifications

  • Minimum BS in Life Sciences, advanced degree preferred
  • 2-3 years of experience working within the human research regulatory environment
  • Current working knowledge of FDA regulations as it pertains to human research, GCP, and International Council for Harmonisation guidelines
  • Knowledge of clinical trial safety issues
  • Excellent interpersonal skills and attention to detail
  • Experience interacting with clinical sites regarding regulatory compliance as it pertains to human clinical research

Note: Some travel may be required for this position

Research Administrator III

FH Vaccine and Infectious Disease Division
Category: Grants and Contracts
Seattle, WA, US
Job ID: 14214

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. The Center’s five scientific divisions collaborate to form a unique environment for conducting basic and applied science. Vaccine and Infectious Diseases Division (VIDD), works to eliminate or minimize the impact of globally significant infectious diseases. Within VIDD is the Statistical Center for HIV/AIDS Research & Prevention (SCHARP) which provides statistical support and data management to researchers worldwide in the fight against HIV/AIDS with active studies in the U.S., Africa, Latin America, Asia and Europe. Join us and make a difference! Careers Start Here. 

 

Biostatistics, Bioinformatics, and Epidemiology  (BBE) and the Statistical Center for HIV/AIDS Research and Prevention (SCHARP) are looking for a Research Administrator III. The Research Administrator III will work independently and collaboratively to coordinate grant/contract proposals and renewal submissions; monitor project budgets; advise the Statistical Center for HIV/AIDS Research and Prevention (SCHARP) Director and its Senior Leadership Team of the current budget status and projections; and interact with Center personnel and external organizations regarding fiscal aspects of the projects/program.

Responsibilities

This is a multi-faceted position with a range of fiscal responsibilities. The individual in this position must be able to work independently and prioritize tasks to meet grant/contract submission and reporting deadlines for a very active research portfolio.  This individual will manage the day-to-day grant/contract operations associated with multiple large DAIDS (Division of AIDS) Network Grants, or equivalent, within the Biostatistics, Bioinformatics, & Epidemiology (BBE) program in the Vaccine and Infectious Disease Division.  This includes but is not limited to monthly reconciliation and financial reporting; developing, modifying, and maintaining shadow-books and ad-hoc reports using complex excel formula heavy tools; resolve issues as needed for the timely conveyance of funds; and act in an advisory capacity for SCHARP’s Director and leadership team. The person will perform complex fiscal analyses and financial reporting, including strategic planning, problem solving, interpreting, reviewing and providing recommendations.

 

Pre-Award Activity:

  • Work closely with SCHARP’s Director and leadership team and other Faculty and Principal Investigator(s) to prepare and submit grant and contract applications to funding agencies, ensuring all forms are completed correctly, all content is included, and the application receipt deadline is met.
  • Assists SCHARP as it navigates the grant proposal process. Understands all parts of the application process and the different requirements of various funding sources.  Interpret Request for Applications (RFAs), create and communicate timelines, complete non-technical/non-scientific portions of the submissions, and oversee institutional signoff.
  • With input from SCHARP’s Director/Principal Investigator, develop the budget and related financial portions of the application. This may include international and domestic subawards.  Ensures that content is accurate, complete, and in compliance with the governing regulations. 
  • Offer editing and formatting assistance with proposals, ensuring sponsor requirements are met. Review all sections for consistency of terms, clarity of writing, and response to application instructions.
  • Understand and has a facility with the range of forms that Fred Hutch and the various funding agencies require.
  • Secure the necessary signatures for grant and contract applications, and tracks the approval process to insure that all necessary permissions are documented prior to the grant/contract deadline for submission.
  • Identify sources for additional funding, supplements, and anticipates all competing and non-competing reports.

 

Post-Award Activity:

  • Responsible for post-award oversight by reviewing and interpreting notice of award, create booking budgets, active management of commitments and budgets, prepare budget forecasts, monthly financial analyses and ad-hoc reports. Collaborate closely with SCHARP’s Director and leadership team, Principal Investigators, and other staff..
  • Initiate, review, and monitor subawards/subcontracts for spending and compliance.
  • Use appropriate tools of the Finance section to document the chronology of grant/contract preparation and administration in order to keep colleagues and supervisor informed of the most current status. Maintain grant/subcontract files in electronic format.
  • Works directly with Fred Hutch Office of Sponsored Research staff to resolve questions and issues related to grants and contracts, including closeout, cost transfers, supplement requests, carry-forwards, funder invoice backup requirements, interim reporting, re-budgeting, and no cost extensions.
  • Assist with expense approval and invoice processing, assuring that charges are appropriate, invoices are paid in a timely manner, and charges are allocated to the correct budget.
  • Assist in the preparation and monitoring of Institutional Review Board (IRB) documentation, particularly as it relates to grants management.
  • Understands the policies and procedures of the NIH and other funding agencies in significant detail and tracks changes to those policies and procedures on a timely basis.
  • Participates as an active contributor in meetings.

Qualifications

Required:

  • BA in Accounting, Finance, Public Administration, or related field or equivalent experience
  • Three years in pre-award and post-award grant and contract management.
  • Knowledge of relevant regulatory requirements affecting sponsored research, and ability to apply this knowledge.
  • Effective and professional oral and written communication skills, with the ability to tailor communications to specific audiences.
  • Ability to navigate complex internal systems and departments while exercising sound judgement and discretion.
  • Proficient with complex budget development and use of reporting tools.
  • Advanced skills in Word, Excel (Pivot tables & formulas), Adobe Acrobat Pro, Outlook and Power Point. 
  • Excellent time management and prioritization skills, with the ability to effectively manage multiple and competing demands.
  • Demonstrated ability to function independently while exercising skill and informed professional judgment.
  • Highly organized and detail oriented. 
  • Demonstrated ability to work successfully as part of a diverse team. 

 

Preferred:

  • Experience with National Institute of Health (NIH) awards, namely Cooperative Agreements.

Research Finance Assistant Director

FH Vaccine and Infectious Disease Division
Category: Grants and Contracts
Seattle, WA, US
Job ID: 14259

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.


The HIV Vaccine Trials Network (HVTN) Laboratory Center is part of an international collaboration of scientists and educators searching for effective and safe vaccines. The HVTN’s mission is to facilitate the process of testing preventive vaccines against HIV/AIDS. The Laboratory Center has an annual budget of more than $25 million and employs approximately 200 employees throughout the program. The organization conducts all phases of clinical trials from evaluating experimental vaccines for safety and the ability to stimulate immune responses through to testing vaccine efficacy. The HVTN Laboratory Center is seeking an Research Finance Assistant Director.


The Research Finance Assistant Director is responsible for driving all activities related to financial planning, grants and contracts, bugeting and analysis for the HVTN Laboratory Center, related grants and Division activities. This position will report to Director of Program Operations, Immunology and Vaccine Development (IVD) Program and will be a valued consultant to the Senior Vice President and Director, VIDD/HVTN Principal Investigator. The position will drive the international grants and contracts, budget and planning process for the Laboratory Center, as well as perform financial analysis. This position will provide strategic direction for a long-range financial view of the grant life cycle and beyond, while taking into consideration internal and external variables and constraints. Significant experience in complex sponsored research projects and financial analysis as well as a demonstrated track record as a leader who values teamwork, collaboration and communication are critical for this role. The ability to effectively communicate financial complexities to a range of audiences is essential.


The Research Finance Assistant Director will also manage a small team and will leverage Division and organizational resources to accomplish goals. In addition, this position will work closely with HVTN Leadership Operations Center, HVTN Statistical Data Management Center, Finance and Accounting as well as across functions (Office of General Council, Business Development & Strategy, IT and Human Resources). The position requires an ability to direct and manage multiple priorities, quickly analyze situations and make sound decisions using effective time management skills, good business acumen, and administrative judgment.

Responsibilities

A. Financial Strategy and Operations

  • Provide direction and support to the Senior Vice President and Director, VIDD/HVTN Principal Investigator, on the financial strategy and planning of the HVTN Laboratory Center and related activities.
  • Develop and maintain key reports for reporting performance against the budget, internal and external requirements to drive accountability and transparency. Prepare information and reports that forecast trends, analyze performance results, and address financial concerns.
  • Establish and drive the annual budget and planning process including communicating across HVTN programs and Center leadership.
  • Oversee and monitor all grant and fiscal activities within the HVTN Laboratory Center Programs including all national and international sites. Establish and comply with financial requirements of NIH and/or the specific funding agency as well as Fred Hutch policies.
  • Assist the Director of Program Operations-IVD and VIDD Senior Operations Director and in the development of short and long term planning of financial resource management, in monitoring spending levels on accounts, advising them of any change in spending status, and troubleshoot/resolve problems or questions regarding budgets.

B. Team Leadership

  • Manage a small team of fiscal staff.
  • Establish a regular cadence of HVTN Laboratory Center Financial meetings including the tracking and monitoring of agendas and action items.
  • Serve as coordinator and contact between members, study investigators, oversight committee and working group leads on all financial matters.
  • Serve as a special advisor to VIDD financial teams for financial management related to sponsored and non-sponsored finance, forecasting and best practice.  

C. Financial Reporting and scientific related visits/meetings

  • Coordinate specific reports as requested by the Division of AIDS, NIH (DAIDS)
  • Serve as the primary point of contact on all post-award financial activities for sponsor communications in coordination with the Principal Investigator.
  • Oversee the submission of the annual progress report including budgets to DAIDS and related reports.
  • Maintain communications and track fiscal team group progress. Communicate and track timelines and milestones.
  • Create and maintain a system or executive report for portfolio financial reporting for the Senior Vice President and Director, VIDD/HVTN Principal Investigator that includes summary and detailed reports for each grant and active account.
  • Develop reports and/or systems that forecast trends, analyze performance results, and address financial concerns.

D. Other Duties

  • Continuously improve the budget and forecasting process and reports, including championing data structure and support.
  • Assist with financial negotiations related to the Laboratory Center in partnership with Senior Vice President and Director, VIDD/HVTN Principal Investigator, Senior Operations Director, VIDD, Director of Program Operations-IVD, Business Development and Fred Hutch administration, upon request.
  • Perform other related duties as assigned including, but not limited to, financial support related to complex agreements, Board reporting and related due diligence.

Qualifications

Minimum qualifications:

  • Bachelor’s degree in Accounting, Finance or related field; MBA is preferred
  • 7-10 years of progressively complex experience in research finance and/or administration of department financial processes and systems including a minimum of 5 years experience working with sponsored research (NIH required)
  • Minimum three years experience leading a team including direct supervision of staff
  • Advanced Excel modeling skills and proficient in MS Office Suite applications
  • Excellent oral and written communication skills
  • Experience with Tableau and related data presentation software
  • Knowledge of NIH grant application procedures, budget monitoring, databases, and financial terms

 

Key skills and abilities

  • Excellent attention to detail and the ability to work independently are essential to success in this position, as are good communication and organizational skills
  • Ability to work under pressure, and maintain confidentiality
  • Ability to prioritize multiple tasks, organize, and work both independently and as part of a team
  • Excellent attention to detail and the ability to work independently are essential to success in this position, as are good communication and organizational skills
  • Must be flexible and willing to work some evenings and weekends as needed

Research Project Manager

FH Vaccine and Infectious Disease Division
Category: Biostatistics, Bioinformatics and Computational Biology
Seattle, WA, US
Job ID: 12839

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.

 

The Statistical Center for HIV/AIDS Research and Prevention (SCHARP) at Fred Hutch is a full service statistical and data management center focused on HIV prevention research. SCHARP has an annual budget of over $40 million, more than 180 employees and is currently managing over 40 active phase I – III clinical trials in over 150 clinical sites around the world. SCHARP is seeking a Research Project Manager.


The SCHARP Research Project Manager reports to the SCHARP Sr. Manager of Lab Data Management and has responsibility for overseeing a diverse portfolio of lab data management and statistical data analysis projects in support of pre-clinical and clinical trials conducted by SCHARP’s research partners. This role will plan, coordinate, and monitor activities among staff in the SCHARP lab data and data analytics teams in support of research projects under the guidance of SCHARP Program and Portfolio Management team.

Responsibilities

The Research Project Manager will:

  •  Manage research projects as assigned.
  •  Assist Program and Portfolio Management with intake and statement of work development.
  •  Define project requirements, scope of work, and schedule including milestones.
  •  Work closely with functional managers to plan resources and/or adjust project timelines in negotiation with stakeholders.
  •  Plan and coordinate activities between third party labs, the SCHARP Lab Data Management, and the SCHARP Data Analytics teams.
  •  Monitor project execution and progress against milestones and deliverables.
  •  Maintain and provide project status information for stakeholders to include issues and risks.
  •  Organize and facilitate regular status meetings with project team, preparing and distributing minutes, agendas, and other materials as needed.
  •  Other responsibilities as assigned and determined.

Qualifications

Minimum Skills/Requirements

  • 4 Year Degree and two years of related experience; experience in lieu of degree acceptable.
  • Experience with research lab data and assays
  • Excellent verbal and written communication skills, strong attention to detail
  • Advanced user of Microsoft Office Suite of tools, Excel in particular, required.
  • Must work well independently and be self-motivated
  • Strong organizational and planning skills

Preferred Qualifications

  • Experience with clinical trials preferred.
  • Experience using project management software (SmartSheet, MS project, etc…)
  • Experience managing or coordinating lab data research projects

Research Technician I-II

FH Vaccine and Infectious Disease Division
Category: Laboratory Research Sciences
Seattle, WA, US
Job ID: 14082

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.

 

The Goo Lab within the Vaccine and Infectious Disease Division is seeking an outstanding Research Technician I/II to perform lab management duties as well as experiments to characterize the role of antibodies in flavivirus immunity and pathogenesis. By using multi-disciplinary tools (virology, immunology, epidemiology, molecular biology, genomics, gene editing, and biochemistry), our ultimate goal is to inform vaccine design and discover drug targets. 

Responsibilities

  • Culture, maintenance and transfection of mammalian cell lines and/or primary cells
  • Virus production, purification, and titering
  • Viral infection and inhibition assays and measurements using flow cytometry and qPCR
  • Cloning, PCR and other molecular biology protocols
  • Protein expression, purification, and analysis
  • Nucleic acid extraction and NGS library preparation
  • Data analysis, careful documentation, oral and written communication of experimental results
  • Ordering, maintaining, and generating inventory of lab reagents and equipment
  • Assist in preparing and maintaining SOPs and biosafety documents
  • Other duties as assigned

Qualifications

  • BS or MS with 2+ years of rigorous laboratory experience (experiment design, execution, optimization, troubleshooting, data analysis)
  • Extensive experience in mammalian cell culture and molecular biology techniques such as PCR, cloning, and nucleic acid extraction
  • Willingness to work with clinical specimens and biohazardous/infectious agents (BSL2/BSL2+)
  • Exceptional organizational and communication skills
  • Highly detail oriented and self-motivated
  • Ability to show initiative, learn quickly, and work independently and responsibly in a collaborative environment

Preference will be given to candidates with experience in the following areas:

  • Lab management (ordering, inventory, equipment maintenance, etc.)
  • CRISPR/Cas9-based genome editing
  • Virology
  • NGS library preparation and analysis
  • Flow cytometry
  • Handling of BSL2 pathogens
  • Basic knowledge of programming language (Python, R, etc.)

SAS Statistical Programmer III

FH Vaccine and Infectious Disease Division
Category: Biostatistics, Bioinformatics and Computational Biology
Seattle, WA, US
Job ID: 13941

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. The Center’s five scientific divisions collaborate to form a unique environment for conducting basic and applied science. Vaccine and Infectious Diseases Division (VIDD) works to eliminate or minimize the impact of globally significant infectious diseases. Within VIDD is the Statistical Center for HIV/AIDS Research & Prevention (SCHARP), which provides statistical support and data management to researchers worldwide in the fight against HIV/AIDS with active studies in the U.S., Africa, Latin America, Asia and Europe. Careers Start Here.


The Statistical Center for HIV/AIDS Research and Prevention (SCHARP) at Fred Hutch is a full service statistical and data management center focused on HIV prevention research. SCHARP has an annual budget of over $40 million, more than 180 employees and is currently managing over 40 active phase I – III clinical trials in over 150 clinical sites around the world. SCHARP is seeking a Statistical Programmer III.

 

With guidance, the Senior Statistical Programmer provides statistical programming expertise within SCHARP by coordinating with statisticians to write efficient, re-usable, and easily maintainable code that access, analyze and report data descriptives and analyses. The incumbent primarily uses SAS; additional statistical and analytical software programs are used as needed. Core to the role is the ability to communicate effectively, work collaboratively with colleagues and be responsive to the needs of both internal and external customers within an environment of mutual cooperation and respect. The Senior Statistical Programmer shows independence in management of workload and production of quality output, as well as technical expertise that contributes to the programmatic infrastructure of the Statistical Programming group.

Responsibilities

Responsibilities will include a subset of the following, based on network(s) supported:

  • Gather and document requirements for developing or modifying existing programs and systems
  • Define and edit mock tables, listings and figures (TLFs) and analysis dataset specifications
  • Generate, document, and maintain analysis datasets
  • Create ad hoc, standard and study-specific reports (e.g. SMC, DSMB, SMB); may perform cross-study reporting
  • Test and de-bug programs and maintain version control on production programs and scripts
  • Design and develop new work instructions (WIs) and updates to existing
  • May coordinate efforts to standardize WIs or processes across studies
  • Develop and maintain automation of routine analysis data and reporting tasks
  • Contribute to good programming practices, and cross-group programming initiatives and code libraries
  • Work with clinical programmers, labs, statisticians, and other statistical programmers to resolve data quality, processing, and analysis issues
  • Contribute to mentoring and training of junior Statistical Programmers and may supervise as needed

Qualifications

Required

  • Bachelor’s degree in Computer Science or a scientific, technical, or health-related field
  • At least four years of experience as a SAS programmer on PC/Unix platform; Preferred experience programming in support of clinical trials, statistical programming in a clinical research setting or other health research programming support
  • Demonstrated ability to communicate effectively in a matrix management environment as a member of several project teams
  • Demonstrated ability to multi-task and appropriately prioritize work assignments
  • Knowledge of and experience with clinical trials research data
  • Knowledge of and experience with biostatistics or statistical analyses in a clinical trials setting
  • Advanced SAS programming skills
  • Strong reporting and SAS macro development abilities
  • Knowledge of SAS (including graphics experience) and other programming languages
  • Ability to use Perl or other scripting languages for text manipulation and automated job control

 

Preferred

  • Graduate degree in computer science or a scientific, technical, or health-related field
  • Knowledge of CDISC standards (SDTM and ADaM)
  • Experience using version control tools

SDTM Specialist

FH Vaccine and Infectious Disease Division
Category: Biostatistics, Bioinformatics and Computational Biology
Seattle, WA, US
Job ID: 13001

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.


The Statistical Center for HIV/AIDS Research and Prevention (SCHARP) at Fred Hutch is a full service statistical and data management center focused on HIV prevention research. SCHARP has an annual budget of over $40 million, more than 180 employees and is currently managing over 40 active phase I – III clinical trials in over 150 clinical sites around the world. SCHARP is seeking a Data Standards Analyst. Under general supervision, the Data Standards Analyst contributes to the coordination and management of clinical data standards and production of standard datasets within SCHARP. The incumbent provides subject matter expertise in CDISC data standards, supports coordination efforts with SCHARP staff and network partners to standardize the collection and tabulation of clinical trials data, coordinates and/or leads CDISC working groups, drafts SDTM and ADaM metadata and conversion specifications as well as CRF Global Library form content, maintains awareness of publication updates from CDISC and other data standards or regulatory agencies that impact SCHARP data standards, and configures data transformations to provision SCHARP SDTM data tables from CRF and other data pipelines to SCHARP Programmers and Statistical Research Associates via a clinical data warehouse.


Core to the role is a deep understanding of data standards and data transformations, the ability to communicate effectively, work collaboratively with colleagues and be responsive to the needs of both internal and external customers within an environment of mutual cooperation and respect.

Responsibilities

  • Reviews study builds to ensure they are following Global Library specifications and review and/or approve of the changes as necessary.
  • Stays informed of updates to CDISC data specifications; incorporates new versions of SDTM into SCHARP SDTM and advises to others in SCHARP on CDASH, SDTM and ADaM.
  • Works with study teams to lead the definition and documentation of per study SDTM metadata and conversion specifications and ensures alignment with organizational data standards.
  • Draft and/or update Global Library form content as needed based on requirements from SCHARP staff and network partners.
  • Draft and/or review SDTM metadata and conversion specifications and final datasets.
  • Defines and documents per study clinical data transformations to SDTM+- from data collection formats such as CDASH.
  • Implements clinical data transformations of source data to SCHARP SDTM using database ETL tools. Specifies complex transformations and consults with Programmers, as needed, to implement.
  • Reviews and validates derived SCHARP SDTM datasets using Pinnacle 21 to ensure compliance with published specifications.
  • Coordinates internal CDISC training to SCHARP and our partners as appropriate and provides routine updates to SCHARP staff to ensure current and new staff are aware of materials and training.
  • Participates in process definitions and SOP development as needed.

Qualifications

Required

  • Bachelor’s degree in Library Sciences, Informatics, Information Systems, Computer Science or other relative discipline.
  • At least two years of experience in data management in clinical research and/or SDTM implementation and conversion experience.
  • Working knowledge of CDASH, SDTM and ADaM.
  • Excellent written and verbal communication skills, with the ability to work well in multi-faceted teams.
  • Experience as a member of a team completing regulatory submissions.
  • Expertise using Microsoft Excel.

Preferred

  • Experience building transformation pipelines using modern ETL tools such as IBM InfoSphere DataStage, Pentaho/Kettle, SQL Server Integration Services, or other.
  • Knowledge of relational database structures and complex data systems.
  • Experience working with data documentation formats such as CSV, JSON, and XML.
  • Experience programming with a modern procedural, declarative, or statistical programming language such as SAS, Perl, Python, Shell or SQL.
  • Experience working in an environment governed by Good Clinical Practices, Good Clinical Data Management Practices, or other FDA guidelines.
  • Experience with Electronic Data Capture (EDC) systems.

Senior Clinical Data Coordinator

FH Vaccine and Infectious Disease Division
Category: Biostatistics, Bioinformatics and Computational Biology
Seattle, WA, US
Job ID: 13760

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.


The Statistical Center for HIV/AIDS Research and Prevention (SCHARP) at Fred Hutch is a full service statistical and data management center focused on HIV prevention research. SCHARP has an annual budget of over $40 million, more than 180 employees and is currently managing over 40 active phase I – III clinical trials in over 150 clinical sites around the world. SCHARP is seeking a Senior Clinical Data Coordinator (Sr CDC) who monitors the collection, processing, performs routine data entry and quality control of study data. The Sr CDC work within a network/study/protocol team to support the policies and goals of each project assigned. They develop and maintain successful working relationships with their team and specific research sites to ensure and maintain data integrity and quality.


The Sr CDC adheres to SCHARP Standard Operating Procedures (SOPs), Work Practice Guidelines (WPGs), applicable clinical trial regulations, and study confidentiality requirements.

Responsibilities

The Sr Clinical Data Coordinator will work under the supervision and mentoring of Sr. Clinical Data Managers and departmental leadership. The Sr CDC uses judgment in making decisions regarding routine data management tasks. They will refer all non-routine decisions for the management of study data to study/protocol leads and/or departmental leadership. Responsibilities may include some or all of the following:

  • Perform routine data entry including first and second pass validation as required.
  • Adhere to current data entry priorities using appropriate tools and resources.
  • Add and resolve QC notes to data fields.
  • Act as liaison for data management issues between SCHARP study teams and research sites.
  • Attend assigned SCHARP study team meetings and conference calls.
  • Assist in development of Case Report Forms for assigned studies.
  • Manage study data for assigned studies.
  • Assist in the maintenance of the study database including routine revisions or additions.
  • Monitor study data to insure the quality and completeness of the data submitted by implementing quality control procedures as appropriate per CDMS.
  • Generate QC reports for site review and correction as well as a variety of other reports as required.
  • Evaluate study data for protocol compliance.
  • Assist in production and review of Data Operations SOPs and WPGs.
  • Assist Data Operations staff in resolving non-routine data entry issues.
  • Perform additional tasks as appropriate and assigned.

Qualifications

  • Bachelor’s degree or equivalent, preferably in a health-related or scientific discipline.
  • 2+ years’ experience in the pharmaceutical/clinical research environment as Clinical Data Coordinator or equivalent role.
  • EDC experience required. Working knowledge of Medidata Rave highly desirable.
  • Demonstrated expertise in relevant clinical data management activities.
  • Working knowledge of ICH/GCP guidelines and FDA regulations.
  • Familiarity with all phases of clinical trials and ability to adapt to study requirements.
  • Strong verbal and written communication skills. Ability to understand and follow instructions and guidelines; able to pick up new tasks quickly; willing to ask questions when a task is not fully clear.
  • Ability to exercise independent judgment within generally defined practices and policies. Shows good judgment in interpreting guidelines and in when to seek support.
  • Ability to work independently and to work efficiently under pressure.
  • Consistent, dedicated, versatile and able to prioritize and multi-task.
  • A strong team player with optimistic attitude.

Senior Python Programmer

FH Vaccine and Infectious Disease Division
Category: Clinical Research Support Services
Seattle, WA, US
Job ID: 13818

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.


The Statistical Center for HIV/AIDS Research and Prevention (SCHARP) at Fred Hutch is a full service statistical and data management center focused on HIV prevention research. SCHARP has an annual budget of over $40 million, more than 180 employees and is currently managing over 40 active phase I – III clinical trials in over 150 clinical sites around the world. SCHARP is seeking a Senior Lab Programmer. Under minimal supervision of the Lab Programming Supervisor or Manager, the Senior Lab Programmer provides programming support for Lab data management, reporting, and analysis needs of SCHARP. The Senior Lab Programmer works on complex assignments in a team environment to support the overall mission of SCHARP. Core to the role is communicating effectively with team members and being responsive to the needs of various constituents inside and outside of the Division.

Responsibilities

The Senior Lab Programmer will provide programming support for Lab Data Management services that include work with SCHARP analysis teams, external labs, and Network partners. Lab Data Management services focus on processing Assay and Specimen Data. The Senior Lab Programmer will lead the team in building, maintaining, processing, and troubleshooting all aspects of our production assay data pipelines. The Senior Lab programmer will also support and monitor specimen data reconciliation. Within the Lab Programming team, responsibilities include leading complex projects that work across SCHARP teams, lead team projects to improve team processes and code, and mentor less experienced team members.


Responsibilities may include:

  • Gather and document requirements for developing or modifying existing programs and systems and defining file specifications for data transfer and necessary edit checks and transformations to meet user needs
  • Create, setup, test and maintain Assay data pipelines for analysis
  • Create, setup, test, and maintain Specimen data reconciliation process
  • Work with SCHARP and external lab staff to resolve discrepancies between protocol expectations, case report form data, assay data, and specimen data
  • Create, update, test, and de-bug programs and maintain version control on production programs and scripts
  • Create, test, document, and maintain SCHARP quality control checks
  • Create, test, document, and maintain ad hoc, standard and study-specific reports
  • Lead development of new or updates to work instructions (WIs) and standardization of processes (SOPs)
  • Train external users on data upload procedures and data submission best practices
  • Ability to troubleshoot and resolve lab programming-related issues
  • Take initiative and lead complex, multi-SCHARP team projects
  • Lead team projects in best practices or process improvement
  • Help mentor and advise less experienced team members
  • Apply best programming practices and collaborate with team members
  • Ability to work under pressure and juggle multiple projects
  • Perform other duties as required or assigned

Qualifications

Required

  • Bachelor’s degree in Computer Science or similar degree in a scientific, technical, or health-related field or additional programming training, skill, or experience.
  • 4+ years of experience in Python, SAS or any object-oriented programming language on Linux/Unix platform.
  • Ability to work independently and communicate effectively as part of a project team.
  • Ability to learn new programming skills as needed.


Preferred

  • 5+ years of experience in Python, SAS or any object-oriented programming language on Linux/Unix platform.
  • 1+ year of experience in Database Design and SQL
  • Basic SAS experience
  • Basic JavaScript experience
  • Basic Perl experience
  • Programming experience in multiple languages in a scientific or health related field
  • Basic SVN experience or any major source control application
  • Basic JIRA experience or any major ticket tracking application
  • Knowledge of and experience in programming support of clinical trials, statistical programming, or other scientific research programming support
  • Experience reading, parsing and transforming lab instrument data files programmatically
  • Experience reading, parsing and creating Excel files programmatically
  • Knowledge of laboratory procedures for assays, and work with laboratories to receive assay results
  • Understanding of computerized systems validation

Senior Statistical Programmer

FH Vaccine and Infectious Disease Division
Category: Biostatistics, Bioinformatics and Computational Biology
Seattle, WA, US
Job ID: 13027

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.


The Statistical Center for HIV/AIDS Research and Prevention (SCHARP) at Fred Hutch is a full service statistical and data management center focused on HIV prevention research. SCHARP has an annual budget of over $40 million, more than 180 employees and is currently managing over 40 active phase I – III clinical trials in over 150 clinical sites around the world. SCHARP is seeking a Senior Statistical Programmer. Under minimal supervisions, the Senior Statistical Programmer provides statistical programming expertise within SCHARP by coordinating with statisticians to write efficient, reusable, and easily maintainable code that access, analyze and report data descriptives and analyses. The incumbent primarily uses SAS and R; additional statistical and analytical software programs are used as needed. Core to the role is the ability to communicate effectively, work collaboratively with colleagues and be responsive to the needs of both internal and external customers within an environment of mutual cooperation and respect. The Senior Statistical Programmer works on complex assignments, shows independence in management of workload and production of quality output, as well as technical expertise that contributes to the programmatic infrastructure of the Statistical Programming group. The Senior Statistical Programmer may also mentor and/or supervise a junior statistical programmer.

Responsibilities

Responsibilities may include:

  • Gather and document requirements for developing or modifying existing programs and systems
  • Define and edit mock tables, listings and figures (TLFs) and analysis dataset specifications
  • Generate, document, and maintain analysis datasets
  • Create ad hoc, standard and study-specific reports (e.g. SMC, DSMB, SMB); may perform cross-study reporting
  • Test and de-bug programs and maintain version control on production programs and scripts
  • Design and develop new work instructions (WIs) and updates to existing WIs.
  • May coordinate efforts to standardize WIs or processes across studies
  • Develop and maintain automation of routine analysis data and reporting tasks
  • Contribute to mentoring and training of junior Statistical Programmers as needed

Qualifications

Required

  • Bachelor’s degree in computer science or a scientific, technical, or health-related field
  • At least five years of experience in SAS or R programming, with additional experience in other programming languages including a scripting language
  • At least two years of experience in support of clinical trials, in a clinical research setting or other health research setting;
  • Demonstrated ability to communicate effectively in a matrix management environment as a member of several project teams
  • Demonstrated ability to multi-task and appropriately prioritize work assignments
  • Knowledge of and experience with clinical trials research data
  • Knowledge of and experience with biostatistics or statistical analyses in a clinical trials setting
  • Knowledge of R (graphics experience) and other programming languages
  • Strong SAS reporting and macro development abilities
  • Advanced SAS programming skills
  • Ability to use Perl or other scripting languages for text manipulation and automated job control

Preferred

  • Graduate degree in computer science or a scientific, technical, or health-related field
  • 5+ years of statistical programming in a clinical research setting.
  • Knowledge of CDISC standardization practices
  • Knowledge of laboratory data

Software Development Engineer

FH Vaccine and Infectious Disease Division
Category: Information Technology
Seattle, WA, US
Job ID: 13239

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.


The Statistical Center for HIV/AIDS Research and Prevention (SCHARP) at Fred Hutch is a full service statistical and data management center focused on HIV prevention research. SCHARP has an annual budget of over $40 million, more than 180 employees and is currently managing over 40 active phase I – III clinical trials in over 150 clinical sites around the world. SCHARP is seeking a Software Developer with professional experience to add to our development team.

Responsibilities

  • Implement and maintain systems within a validated software development lifecycle 
  • Participate in agile requirements gathering, design and tasking 
  • Provide operational support for existing systems 
  • Work on a project team with customers, business analysts, project management and testers 
  • Work on a development team creating and following standards that help with cross training and reducing system maintenance tails 

Qualifications

Minimum: 

  • 3-6 years professional experience in software development 
  • Expertise with modern OOP programming paradigms / languages 
  • Experience with relational data modeling: conceptual and physical 
  • Defining and writing automated unit and functional tests 
  • Detail oriented including the following:  
    • Ability to understand a system of complex interactions 
    • Capable of deep troubleshooting and discovering root causes of problems 
    • Writes unit tests with the same care as product code 
    • Has well-commented code

 

Preferred: 

  • Java full stack web application development experience, both front-end and back-end 
  • Agile development 
  • UNIX systems 
  • PostgreSQL 
  • Javascript, Selenium 
  • Play Framework 
  • Microservice architecture 
  • Docker, Kubernetes, AWS 
  • Functional programming 
  • Working in a regulated environment such as 21 CFR Part 11, Sarbanes-Oxley or HIPPA 

 

Culture: 

  • Work in an organization that strives to make the world a better place.  
  • Work with developers who enjoy crafting quality code and robust performant systems.  
  • Work in vibrant South Lake Union Seattle.  
  • Strong commitment from management to a 40 hour work week.  
  • Benefits include paid vacation, holidays, sick time, medical, dental and vision benefits as well as 403 (b) retirement plan. 

Software Development Engineer

FH Vaccine and Infectious Disease Division
Category: Information Technology
Seattle, WA, US
Job ID: 13236

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.


The Statistical Center for HIV/AIDS Research and Prevention (SCHARP) at Fred Hutch is a full service statistical and data management center focused on HIV prevention research. SCHARP has an annual budget of over $40 million, more than 180 employees and is currently managing over 40 active phase I – III clinical trials in over 150 clinical sites around the world. SCHARP is seeking a Software Developer with professional experience to add to our development team.

Responsibilities

  • Implement and maintain systems within a validated software development lifecycle 
  • Participate in agile requirements gathering, design and tasking 
  • Provide operational support for existing systems 
  • Work on a project team with customers, business analysts, project management and testers 
  • Work on a development team creating and following standards that help with cross training and reducing system maintenance tails 

Qualifications

Minimum: 

  • 3-6 years professional experience in software development 
  • Expertise with modern OOP programming paradigms / languages 
  • Experience with relational data modeling: conceptual and physical 
  • Defining and writing automated unit and functional tests 
  • Detail oriented including the following:  
    • Ability to understand a system of complex interactions 
    • Capable of deep troubleshooting and discovering root causes of problems 
    • Writes unit tests with the same care as product code 
    • Has well-commented code

 

Preferred: 

  • Java full stack web application development experience, both front-end and back-end 
  • Agile development 
  • UNIX systems 
  • PostgreSQL 
  • Javascript, Selenium 
  • Play Framework 
  • Microservice architecture 
  • Docker, Kubernetes, AWS 
  • Functional programming 
  • Working in a regulated environment such as 21 CFR Part 11, Sarbanes-Oxley or HIPPA 

 

Culture: 

  • Work in an organization that strives to make the world a better place.  
  • Work with developers who enjoy crafting quality code and robust performant systems.  
  • Work in vibrant South Lake Union Seattle.  
  • Strong commitment from management to a 40 hour work week.  
  • Benefits include paid vacation, holidays, sick time, medical, dental and vision benefits as well as 403 (b) retirement plan. 

Staff Scientist

FH Vaccine and Infectious Disease Division
Category: Clinical Research Support Services
Seattle, WA, US
Job ID: 14280

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.


The Cancer Immunotherapy Trials Network (CITN), a National Cancer Institute (NCI) sponsored network, and the closely associated industry sponsored Immune Oncology Network (ION), were formed to coordinate the conduct of early (Phase I and Phase II) clinical trials in the area of cancer immunotherapy. These networks are coordinated through a Central Operations and Statistical Center (COSC), which is housed at Fred Hutchinson Cancer Research Center. The goals of this network of leading investigators and institutions is to design and implement biologically-dictated cancer immunotherapy trials using agents and combinations to demonstrate proof-of-concept essential to proceed to Phase III pivotal trials. The associated Central Immune Monitoring Lab (CIML) located at the Fred Hutch is charged with providing high quality immunogenicity and biomarker data that elucidate mechanisms of response to inform these trials.


This Staff Scientist position will work with a group of 6-10 laboratory staff that performs immunological monitoring of human samples for cancer immunotherapy trials. The candidate will work closely with the CIML Laboratory Director and Associate Director and other laboratory team members to manage and contribute to correlative biomarker studies associated with specified clinical trials. In this role they will be involved in developing and performing immunological assays for multi-center clinical trials. A key role will be performing data analyses as well as project management type functions in this setting toward specified studies. This person will be responsible for collecting, analyzing and interpreting data, as well as summarizing data for the Lab Director and the Systems team. They will also contribute to overall general day to day functional activities in support of sample acquisition management critical to the main operations of the research laboratory.


This position reports to the CIML Lab Director. The role supervises lab aides, technicians and students as needed.

Responsibilities

The person in this role will provide both scientific and some project management functions in support of correlative research and biomarker studies toward specified clinical trial objectives. These efforts will initially be primarily focused on organizing and contributing to Flow Cytometry studies, as well IHC other immune monitoring assays as needed. They will take a lead role integrating these data from collaborators and CROs into the Labkey database and interrogating these data for biomarkers associated with clinical response. In that capacity there will be essential project management duties to coordinate correlative studies specific for ION protocols. Responsibilities include, but are not limited to:

  • Serve as a key correlative science team laboratory member to effectively integrate laboratory science results with the operations team and with lab management
  • Plan, coordinate and implement correlative studies as assigned by the Lab Director
  • Perform multiparameter flow cytometry and other cell-based assays
  • Provide Project Management support for specified protocols, overseeing project goals and deliverables, in the context of milestones and associated timelines and resolve project specific issues
  • Record keeping, data collection and analysis, QCing and organizing data for posting on databases for sharing with collaborators; Facilitate data transfer from Correlative Science team to Data Management team
  • Summarize laboratory data for periodic reports of work, including contribution to progress reports and publications
  • Successfully manage multiple projects; Create/update project plans in appropriate project management tools and workflow diagrams
  • Read literature related to research projects
  • Assist in preparation of lab portions of clinical protocol-specific laboratory manuals
  • Assure quality control standards and competencies are met and documented
  • Conduct or coordinate ELISA/Luminex assays to measure cytokine production, if needed
  • Interpret results and recommend modification of procedures as necessary
  • Contribute to validation of new and existing assays
  • Eventual staff management responsibilities will be expected with CIML expansion
  • The candidate will attend relevant technical conferences, as funds permit.

Qualifications

  • PhD degree in immunology or related field, and 6 or more years of relevant laboratory research experience, including flow cytometry, cellular immunology, tissue culture, DNA isolation, Gene Expression Profiling and ELISPOT
  • Demonstrated project management skills, experience and technical aptitude in the setting of a laboratory research environment (PM Certification desired, not required)
  • Extensive experienced in Flow Cytometry including multicolor and Flow Data handling. Familiarity with FACSDiva and Flowjo (9 and/or 10) software essential.
  • Knowledge of the performance of immunologic assays to meet GLP requirements
  • Knowledge of current literature on immunology, tumor immunology, gene expression analyses
  • Familiarity with cell-based assays utilizing a variety of readouts including ELISA, proliferation/viability, CTL, and ELISPOT, preferred
  • Experienced in blood cell subset purification
  • Industry or clinical laboratory experience in the use of immune monitoring
  • Excellent computer, organizational, and record keeping skills.
  • Skilled in data analysis and compilation using computer applications including Excel, PowerPoint, Word, GraphPad Prizm, etc
  • Excellent written and oral communication skills; including ability to write and present data orally
  • Strong interpersonal skills, with the ability to work effectively within an established team environment and a collaborative management style
  • Some supervisory experience a plus
  • Should be highly organized and have a knowledge of laboratory working environments
  • Experience with BSI (IMS) required and LabKey (desired)

Staff Scientist, Computational Biology

FH Vaccine and Infectious Disease Division
Category: Biostatistics, Bioinformatics and Computational Biology
Seattle, WA, US
Job ID: 12571

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first and largest cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.

 

Work in an organization that aims to make the world a better place and is home to three Nobel Prize winners. Enjoy an awesome work-life balance with a strong dedication from management to a 40 hour work week, support for public transit / bike commuting, healthy eating options in the Hutch's cafes and an office across from the water in South Lake Union. Benefits include paid vacation, holidays, sick time, medical, dental and vision benefits as well as 403 (b) retirement plan.


The Gottardo Lab is a Research Lab within the Computational Biology program at the Fred Hutchinson Cancer Research Center. We develop statistical methods and computational tools for managing and analyzing high-throughput biological data including single-cell RNA-seq, flow-cytometry, CyTOF and CITE-seq, to name a few. We then utilize these tools, in collaboration with immunologists and clinicians, to analyze high-dimensional data from pre-clinical and clinical trials in an effort to accelerate the development of new cancer immunotherapies and vaccines. Our lab participates in large collaborative efforts funded by the NIH, Gates Foundation and the CZI including the Human Immunology Project Consortium, the Human Cell Atlas, the Cancer Immunotherapy Trial Network and the Collaboration for Aids Vaccine Discovery.

 

As a lab, we value inclusion and a diversity of backgrounds and perspectives to inform our work. We believe in supporting each other through mentorship and providing resources for professional development. Given these values, we strive to make our recruitment and promotion processes fair and transparent. Therefore, we strongly encourage all individuals with an interest in the position to apply. To learn more about our lab, go to rglab.org.

 

The Gottardo Lab is seeking a PhD level computational biologist to fill a Staff Scientist position to help support large collaborative projects in computational immunology with applications to cancer immunotherapy and vaccine development. The Staff Scientist will have the opportunity be involved in the development of cutting-edge technologies and associated tools for profiling immune responses in blood and tissues at a single-cell resolution and in the application of these tools in innovative pre-clinical and clinical studies. The incumbent will participate in multidisciplinary collaborations involving laboratory-based scientists (immunologists, cancer researchers), clinical investigators, biostatisticians, data scientists, programmers and computational biologists.

Responsibilities

  • Develop and optimize computational pipelines to enable the integration and management of large and complex data sets
  • Develop well-documented, properly tested, open-source software for reproducible research
  • Interpret results from computational and statistical analysis
  • Assist with study design of pre-clinical and clinical trials
  • Participate in the dissemination of research findings
  • Co-author manuscripts for publication
  • Assist supervision of team members in the Gottardo Lab (postdocs, junior computational biologists)
  • Manage and set scientific priorities across projects

Qualifications

Minimum Qualifications:

  • PhD or equivalent degree in bioinformatics, computational biology, biostatistics, statistics, computer science, or a related field.
  • Experience in analysis of next generation sequencing data
  • Excellent programming skills (python, R, C/C++, Java) including best software development practices (e.g. design, unit tests, documentation, code review)
  • Excellent interpersonal, oral and written communication skills
  • Strong work ethic
  • Ability to work in a team, and supervise junior team members
  • Ability to manage multiple projects and to meet deadlines

Preferred Qualifications:

  • Understanding of immunology and/or immunotherapy
  • Experience in single-cell analysis

Technical Project Manager

FH Vaccine and Infectious Disease Division
Category: Biostatistics, Bioinformatics and Computational Biology
Seattle, WA, US
Job ID: 14129

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.


About the Gottardo Lab:

The Gottardo Lab is a Research Lab within the Computational Biology department at the Fred Hutchinson Cancer Research Center. We develop bioinformatics tools for accessing and analyzing high-throughput biological data, such as RNA sequencing and flow cytometry data. You can read more about the lab at www.rglab.org. As a lab, we value inclusion and a diversity of backgrounds and perspectives to inform our work. Given these values, we strive to make our recruitment and promotion processes transparent, fair, and supportive. Therefore, we strongly encourage all individuals with interest in the position to apply.

 

About the Role:

The Technical Project Manager I will play a key role in the success of three projects focused on supporting immunological research. The larger two projects are web applications representing both an early-stage product still being defined as well as a mature application with 2000+ registered users (www.immunespace.org). The final project is a small data management and analysis service to external collaborators.


These projects typically involve 1 to 3 bioinformatics analysts and software engineers from the Gottardo Lab and require collaboration with outside stakeholders at partner institutions. The Technical Project Manager I reports to the Principal Investigator for each project and will be mentored by a senior member of the lab as they come onboard and get up to speed.

 

The ideal candidate will

  • Have a strong interest in science and belief in mission of Fred Hutch
  • Be self-motivated and comfortable working in a research or startup-like environment that requires proactive communication
  • Be Able to balance the needs of all stakeholders with a generous, direct, and non-aggressive approach
  • In cooperation with other team members, help bring best practices, improve existing processes and promote efficiency

Responsibilities

Project Management (75%)

  • Facilitate quarterly discussion with project team and Product Manager/PI to determine and prioritize major deliverables (software features / analyses) and document this in product roadmap.
  • Work directly with developers and analysts to build, refine, and deliver completed features and analyses to stakeholders within established deadlines from the product roadmap
  • Manage projects in accordance with agile / scrum methodology (e.g. groom sprint backlogs, plan and manage two-week sprints, and coordinate stakeholder review) using online task management tool (so).
  • Maintain and produce all project documentation, including meeting agendas, progress reports, issues log and presentations.
  • Support the PI in maintaining strong relationships with funding agencies through grant reporting, in-person presentations, and online updates.

Communications (15%)

  • Drive increased user-engagement of software applications using effective communication and content in appropriate channels, such as monthly teleconference calls, blogs, twitter or LinkedIn posts.

User Research (10%)

  • Develop usability tests, interviews, and surveys to gather feedback from stakeholders (software end users or scientific collaborators) to help inform product decisions and roadmap.
  • Use an online documentation tool (so) to create use case examples, low-fidelity wireframes and user workflows
  • Write functional specifications describing desired features and iterate with developers to design creative and practical solution

Qualifications

Minimum Qualifications

  • Bachelor’s degree or equivalent work experience
  • 1 to 2 years project management experience
  • Has led one software project to completion (feature or larger) with a team of 3 or more
  • Has worked in an agile-style environment
  • Has managed multiple projects at one time
  • Experience in facilitating and building consensus in an interdisciplinary team environment. Able to build successful working relationships with a wide variety of collaborators.
  • Demonstrated experience communicating with high-profile stakeholders in-person and via written correspondence

 

Preferred Qualifications

  • Project management experience with products related to data analysis
  • Some user community management or user research experience, such as being first-line response for troubleshooting a technical product or performing usability testing.
  • Experience developing user-facing communications to promote a technical product or brand online (e.g. blogs, LinkedIn and twitter posts)
  • A background in the life sciences
  • Experience working in a startup or similarly early-stage organization

Technical Project Manager II

FH Vaccine and Infectious Disease Division
Category: Information Technology
Seattle, WA, US
Job ID: 13240

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.


The Statistical Center for HIV/AIDS Research and Prevention (SCHARP) at Fred Hutch is a full service statistical and data management center focused on HIV prevention research. SCHARP has an annual budget of over $40 million, more than 180 employees and is currently managing over 40 active phase I – III clinical trials in over 150 clinical sites around the world. SCHARP is seeking a Technical Project Manager II. Responsible for overall planning, resource coordination, scheduling, and execution of various technology-related projects. Ensures projects are delivered within the planned schedule and scope.

Responsibilities

The Technical Project Manager II is responsible for managing medium, moderately complex projects with teams of up to 8 people that involve up to 2 technologies within a single organizational unit. The Technical Project Manager II reports to the Associate Director, SCHARP TSS.


Responsibilities include:

  • Work with project sponsors and stakeholders to define project requirements, scope, risks, organization, and approach.
  • Manage the creation of project plans, process and data flow diagrams, use case examples, user interaction wireframes, user workflows, conceptual data models, implementation timelines and testing plans.
  • Work with resource managers to obtain resources. Track and manage issues and risks.
  • Manage project and sprint backlogs in accordance with agile methodology (create project/sprint backlogs, plan and manage sprints, and coordinate stakeholder review).
  • Provide leadership and direction to the project team, in alignment with SCHARP’s SDLC, to successful completion of assigned project tasks.
  • Build and maintain strong working relationships with team members, project sponsors and peers. Communicate status to project sponsors, team, and stakeholders.
  • Manage scope, schedule, and resource changes according to defined change control procedures.
  • Serve as project liaison, representing the project to other center departments, affiliated individuals or institutions, and outside organizations.
  • Manage vendor/consultant resources as required by project.
  • Applies technical experience and knowledge in support of business and technology goals.
  • Provides leadership in development of organizational best practices for project management and SDLC.

Qualifications

Minimum Qualifications

  • Bachelor’s degree.
  • A minimum of 4 years of project management with 2 years experience managing medium to complex technology projects.
  • Experience managing multiple technology projects for the full life cycle utilizing a System Development Life Cycle methodology.
  • Experience with agile methodologies such as Scrum.
  • Requires excellent written and verbal communication skills and demonstrated ability to work independently, lead projects and to manage competing priorities in a fast-paced environment.
  • Proven ability to understand technical details and systems architecture, and to translate and communicate between technical teams and stakeholders.

Preferred Qualifications

  • Bachelor’s degree in Computer Science or similar degree in a scientific or technical field.  Agile Certified Practitioner (PMI-ACP) or Scrum Master certification.
  • Project Management Proficiency (PMI-PMP) certification.
  • Experience as a software developer.
  • Experience working in a regulated environment and applying regulations such as 21 CFR Part 11 to IT projects.
  • Experience conducting Computer System Validation, as defined by the FDA, as part of a Systems Development Life Cycle.

Vaccine Trials Project Manager II

FH Vaccine and Infectious Disease Division
Category: Clinical Research Support Services
Seattle, WA, US
Job ID: 14199

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.


The Cancer Immunotherapy Trials Network (CITN) is a National Cancer Institute (NCI) sponsored network initiated to stimulate the conduct of early (Phase I and Phase II) clinical trials in the area of cancer immunotherapy.


The network is coordinated through a Central Operations and Statistical Center (COSC), which is housed at Fred Hutchinson Cancer Research Center. The Network is supported by an NCI grant, and a commitment of substantial NCI services, augmented by Fred Hutchinson Cancer Research Center institutional funds.


We are seeking an energetic individual with substantial background in clinical research for the position of Clinical Trial Manager (CTM). The CTM will report directly to the CITN Administrative Director. The CTM will be responsible for working closely with CITN COSC staff to implement and manage CITN protocols being conducted at Network clinical sites in addition to helping with a variety of protocol development tasks.

Responsibilities

The CTM serves as the primary contact for Network sites and others involved in protocol operations and study conduct. This position will be responsible for the operational management and the oversight of clinical trials within the COSC.

 

Special skills, knowledge and judgment are applied in independently managing site-level project/study operations, in developing methods and materials, in conducting protocol training, and in carrying-out complex, multi-site research management responsibilities. Problems and challenges that arise in the implementation of projects/studies are handled by the CTM, soliciting assistance from other stakeholders and informing the COSC team as appropriate.

  • Manage all operational components of several protocols, working with other stakeholder groups as appropriate.
  • Actively assist in writing and developing protocols and informed consent documents with an emphasis on operations. Represent the protocol team in developing, reviewing and/or revising research materials including SOPs, questionnaires, data collection instruments (e-crfs), educational materials, and recruitment materials in collaboration with other members of the protocol team.
  • Develop, interpret, and administer project/study policies and procedures according to protocol, IRB, grant/contract, data management center, laboratory program and Fred Hutchinson Cancer Research Center
  • Ensure efficient protocol start-up & implementation at study sites by facilitating or liaising between sites, other functional units within the CITN, the developer, the sponsor and others as needed. Manage expectations for COSC, CITN Leadership and sites related to study implementation, including the start-up timeline, enrollment, and site performance
  • Serve as project/study liaison, representing the project/study to other functional units within the CITN. Serve as the first point of contact when problems pertaining to a particular protocol and/or site arise. Ensure rapid resolution of study issues/problems as they arise using appropriate internal and/or external resources. Develop plans for addressing deficiencies at study sites in collaboration with protocol team and other stakeholders.
  • Represent and advocate for sites in strategic & operational discussions. Serve as the primary “go-to person” for site knowledge and site-related queries, including developing training materials to educate clinical sites on all aspects of the protocol.
  • Drawing on knowledge and relationships with sites’ operations, provide input to protocol teams on site expertise and potential obstacles and challenges.
  • Develop site-specific timelines and provide updates on protocol implementation such as enrollment and retention.
  • Plan and attend meetings, monitor activities to ensure study and Network objectives have been met within designated time frame, and coordinate follow-up activities
  • Coordinate development of new sites as appropriate. Assess capacity of study sites to conduct research protocols in accordance with network SOPs, National Cancer Institute (NCI) requirements, and principles of Good Clinical Practice.
  • Contribute to ongoing development of procedures and practices by participating in Operations Meetings and working groups as assigned.

Qualifications

A degree in the health sciences, (i.e., RN, BSN, MPH, etc.) with experience in a clinical research setting is required. A minimum of 5 years experience in a clinical research environment, including at least 3 years experience in the management of complex programs, activities or units is needed. Experience managing clinical sites and multiple clinical projects as the Sponsor, is highly desirable.

 

Excellent written and verbal communication skills, ability to manage a constantly changing list of priorities while staying organized. Flexibility and a sense of humor are essential in this fast paced role. Strong desire to perform a variety of tasks is necessary.

 

SPECIFIC SKILLS

  • Excellent written and oral communication skills
  • Strong skills in facilitating and building consensus in an interdisciplinary team environment
  • Able to multi-task efficiently
  • Ability to build successful working relationships with relevant network partners
  • Actively seeks out new opportunities and responsibilities
  • Self-motivated and able to work independently with minimal supervision using strong organizational, project and time management skills
  • Strong problem solving skills
  • Strong collaborative and leadership skills
  • Excellent organizational skills with keen attention to detail
  • Ability to prioritize competing demands to successfully meet deadlines and project milestones.
  • Extensive knowledge of regulatory aspects of clinical research, e.g., IRB, HIPAA, and FDA requirements for the conduct of research.
  • Clinical trial monitoring or auditing experience a plus
  • Understanding of Sponsor role and responsibilities required

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