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48 Found open positions

Administrative Coordinator II

FH Vaccine and Infectious Disease Division
Category: Administrative Support
Seattle, WA, US
Job ID: 13874

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 an Administrative Coordinator II. The Administrative Coordinator II position resides in the Vaccine and Infectious Disease Division (VIDD) of Fred Hutch and is responsible for providing general administrative services in support of the staff within the Statistical Center for HIV/AIDS Research and Prevention (SCHARP). This position reports to the BBE-SCHARP Administrative Manager.

Responsibilities

Responsibilities may include:

 

  • Provide Director of SCHARP and the SCHARP Senior Management Team support
    • Scheduling
    • Arranging travel
    • Meeting support
    • Credit card reconciliation
  • Provide SCHARP Program-level administrative services
    • Respond to employee administrative requests
    • General office maintenance and support
    • Submit work orders and purchasing requests
    • Maintain shared files, inventories, and other organizational documents
    • Maintain SCHARP webpage and SharePoint sites
    • Answer the main phone line and triage calls as appropriate
  • Assist with Human Resources activities
    • Coordinate on-boarding and orientation activities
    • Generate and track: HR action forms, requests for new hires and affiliates
    • Maintain HR reports and databases, job descriptions and org charts
  • Support staff attendance at conferences and trainings
    • Assist with registration, related travel and reimbursements
    • Obtain required approvals and necessary travel documents
    • Maintain record of approvals
    • Reconcile expenses, track and report against budget
  • Meeting and Event Coordination and Support
    • Maintain budget, and track and report on spending
  • Assist SCHARP, BBE Admin, and faculty with special projects, as needed
  • Perform backup to Administrative Services staff and other responsibilities as required

Qualifications

  • Bachelor’s degree or equivalent
  • 5+ years related experience in an office environment
  • Proficiency with Excel, Word, Outlook, Adobe, SharePoint, and PowerPoint
  • Outstanding customer service and time management skills
  • Detail-oriented with strong organizational skills, able to anticipate upcoming needs and provide outstanding customer service
  • Strong verbal and written communication skills, demonstrated ability to communicate effectively with all levels of personnel, and to establish and maintain positive relationships with internal and external partners
  • Consistent, dedicated, versatile and able to prioritize and multi-task
  • Ability to respond quickly to new instructions, situations, methods and procedures with a calm and professional demeanor. Willing to ask questions when a task is not fully clear.
  • Takes initiative and able to exercise independent judgment in effectively carrying out routine responsibilities within defined policies and procedures. Shows good judgment in interpreting guidelines and in when to seek support
  • Demonstrated ability to work independently as well as within a team. Team player with an optimistic attitude, contributes to healthy team morale, shares responsibility and recognition for work
  • A desire to contribute to building an organizational culture grounded in community, mutual respect and support, inclusiveness and continual growth and learning

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 Manager

FH Vaccine and Infectious Disease Division
Category: Clinical Research Support Services
Seattle, WA, US
Job ID: 13501

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 Data Manager (CDM).

 

The CDM leads and monitors the collection, processing, data entry and quality control of study data. They are responsible for effectively managing timelines, quality and delivery of data for assigned projects that are in support of clinical trials research. They develop and maintain successful working relationships with their team and specific research sites to ensure and maintain data integrity and quality. The CDM works within a network/study/protocol team to support the policies and goals of each project assigned. Applying GCP and GCDMP principles, the CDM manages the protocol/study specific tasks including coordinating clinical and laboratory database deliverables, working with collaborators on data content requirements, leading data quality and closeout activities throughout the data management lifecycle. The CDM adheres to SCHARP Standard Operating Procedures (SOPs), Work Practice Guidelines (WPGs), applicable clinical trial regulations, and study confidentiality requirements and functions with moderate supervision in operational and technical matters within defined procedures and practices.

 

**Please note: This position will be on-site in Seattle, WA. We cannot accommodate a remote worker in this role at this time.

Responsibilities

The Clinical Data Manager (CDM) will manage study/protocols with moderate supervision from senior staff and/or departmental leadership and will use judgment in making decisions regarding routine data management, quality control and liaison tasks. The CDM is the primary SCHARP contact for study/protocol specific implementation, operation, and closeout phases and is responsible study communication, documentation, and training on data collection and management activities for domestic and international research sites for assigned protocol/study(s).   The CDM is a member of the protocol/study team coordinating with both internal and external partners and collaborators to ensure the relevant data are collected and cleaned to meet the needs of the protocol/study and research objectives.

 

For the more experienced CDM, s/he may participate in training and orientation of new CDMs when appropriate, and may serve as a CDM mentor. Assignment of projects/trials is commensurate with previous experience and can be assigned across scientific areas or study phases. S/he will be coordinating larger, more complex studies and/or a larger volume of studies with minimal assistance.

 

1. Manages study/project implementation including but not limited to leading SCHARP team members through CRF, lab, and other data collection processes, reporting and analysis requirements, study/project documentation and training.

2. Effectively manage assigned protocol/study, establish timelines and milestones, monitor and communicate ongoing status and progress.

3. Ensure rapid resolution of issues/problems using appropriate internal and/or external resources. Track and manage issues escalating to the appropriate level in a timely manner.

4. Participate in development of protocol/study from draft protocol to optimize collection of accurate and high-quality data.

5. Work with project sponsors, stakeholders and SCHARP team members to define project requirements, scope, risks, staffing requirements, organization and approach.

6. Act as subject matter expert for data management issues between SCHARP study teams and external domestic and international research sites for assigned studies.

7. Assist in development of Case Report Forms (CRFs) for assigned studies.

8. Assist in the design of the protocol/study specific database for assigned studies.

9. Assist in the maintenance of the study database including routine revisions or additions to include the design and/or modification of routine and existing study database edit check programs for assigned studies.

10. Perform User Acceptance Testing (UAT) for assigned studies.

11. Monitor study data to insure the quality and completeness of the data submitted by implementing quality control procedures.

12. Generate QC reports for site review and correction as well as a variety of other reports as required.

13. Evaluate study data for protocol compliance.

14. Assist in the maintenance of documentation of the study database and other related data management programs and/or applications.

15. Assist in the review of new and revised departmental SOPs and WPGs.

16. Ensure that SCHARP meets its obligations in accordance with Good Clinical Data Management Practices (GCDMP). 

17. Perform other duties as assigned.

Qualifications

Minimum:

Bachelor’s degree or equivalent, preferably in a health-related or scientific discipline
2+ years’ experience in the pharmaceutical/clinical research environment as a Clinical Data Coordinator/Clinical Data Manager
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 when to seek support.
Ability to work independently and to work efficiently under pressure. 
Consistent, dedicated, versatile and able to prioritize and multi-task.
Familiarity with MS Office software and familiar with data management practices.   
 

Preferred:

4+ years' experience in the pharmaceutical/clinical research environment as a Clinical Data Manager.
Experience using SAS and relational databases (e.g. MS SQL Server, MS Access, or Oracle)
Experience in clinical trial and regulated research settings desired. Experience with managing immunology, infectious disease and/or virology research projects desired.

Prior experience in HIV or infectious diseases, clinical trial operation management and/or protocol development preferred.
Experience in facilitating and building consensus in an interdisciplinary team environment and able to build successful working relationships with a wide variety of collaborators.
Knowledge of clinical research, FDA & ICH, GCP, GCDMP, and related regulatory requirements

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       

Computer System Validation Specialist & Tester

FH Vaccine and Infectious Disease Division
Category: Information Technology
Seattle, WA, US
Job ID: 13235

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 Computer Systems Validation Specialist. The Computer System Validation Specialist uses best practices to develop, conduct, and document validation of clinical research systems in accordance with federal guidance on computer systems validation. This role works with Business Analysts, Developers, and Project Managers within an agile SDLC to ensure that computer systems function as designed in a consistent and reproducible manner, and meet business, functional, and regulatory requirements. This role reports directly to the Associate Director, Technology Systems & Services.

Responsibilities

The person in this position is responsible for leading or contributing to the planning and documentation of computer system validations. They will also participate as a Tester in developing, maintaining, and conducting system and integration testing for SCHARP systems, in support of computer system validation. In addition to testing, they will be responsible for developing and maintaining a system test methodology and computer system validation procedures that complements the SCHARP SDLC. Tests, test methodology, and computer system validation artifacts will be thoroughly documented according to best practices. This person will work as part of project and validation teams, responsible for writing and conducting tests, as part of system upgrade teams, responsible for conducting regression testing, and independently and proactively developing test methodology, and improving computer system validation practices.

 

Responsibilities may include:

  • Develop, document, implement, and grow system test and computer system validation methodology in alignment with best practices and regulatory guidance
  • Develop and maintain system test plans that include grey and black box testing of both in-house developed and COTS systems
  • Conduct and document computer system validations, and ensure that validation artifacts, including validation plans, requirements documents, risk assessments, traceability matrices, are accurate and documented correctly
  • Write, document, and execute system Operational Qualifications (OQ) as part of computer systems validation
  • Conduct system and integration and regression testing and document results
  • Play the role of Quality Assurance / Test for assigned applications as part of an agile SDLC

Qualifications

Minimum Qualifications

  • 2+ years of experience in test
  • Direct experience with computer systems validation
  • Direct experience with software testing methods and processes
  • Strong communication and documentation skills
  • Able to define clear and concise processes
  • Must be team-oriented and collaborative
     

Desired Qualifications

  • Bachelor’s Degree in Computer Science, Computer Information Systems, Informatics or related field
  • Experience working in a clinical research environment
  • ITIL experience or certification
  • Experience with test automation frameworks and tools
  • Proficient in a modern scripting language such as Perl, Python, or JavaScript
  • Experience querying database systems

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. SCHARP is seeking a Junior Electronic Data Capture (EDC) Programmer. This is an entry level position that supports the SCHARP clinical data management team. They will 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

Responsibilities may include:

  • 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 in Computer Science, Information Technology, Life Sciences, a related technical field, or a foreign degree equivalent
  • Fundamental understanding of configuring/programming a clinical trial EDC system, clinical trials, EDC systems, and Data Management.
  • 1-3 years of demonstrated programming skills (C#, SQL, or similar programming experience highly desirable)
  • 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

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: Post-Doctoral Research Fellows and Associates
Seattle, WA, US
Job ID: 14125

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 Prlic laboratory in the Vaccine and Infectious Disease Division is recruiting a postdoctoral research fellow to work with an interactive group of scientists to study immune responses at the maternal-fetal interface.

Qualifications

A PhD in immunology is required with 3+ years of experience in an academic or industry setting. A successful candidate will have extensive experience with flow cytometry, cell culture and complex experimental planning. The candidate must be responsible, organized, self-motivated and able to efficiently manage time and experiments, while also participating in collaborative lab projects.

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: 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
  • 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

Project Coordinator II

FH Vaccine and Infectious Disease Division
Category: Administrative Support
Seattle, WA, US
Job ID: 14046

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

 

Requirements:

  • Project Coord. I- Minimum of one-year post-master's or three years post-bachelor's project coordination experience in a research setting
  • Project Coord II- Minimum of three years post-master's or five years post-bachelor's project coordination experience in a research setting
  • Excellent written and verbal communication skills
  • Cover letter accompanying this application 

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

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

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 - Corey Lab

FH Vaccine and Infectious Disease Division
Category: Laboratory Research Sciences
Seattle, WA, US
Job ID: 14100

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.


Overview: This is a part-time position (70% FTE) in the Corey lab to work with faculty member, Staff Scientist and laboratory staff. The lab works on Herpes Simplex Virus (HSV) and CD8 T cell responses.


Working conditions: This position will be required to work from 3-8 p.m. M-F to complete the work.

Responsibilities

  • Build ten x genomic libraries for research project
  • Process plasma samples for assays
  • Conduct other bench experiment to generate data. Techniques may include: in situ tetramer staining, DNA and RNA extraction, quantitative PCR and RT-PCR, FACS analysis, Western blot, tissue culture, viral infection and titration, transfection, gene expression and RNA interference, etc.;
  • Search public databases and literature for conceptional and methodological information;
  • Analyze data and organize professionally for laboratory meeting presentations
  • Ordering supplies, making reagents, maintenance of equipment, lab safety

Qualifications

Education and training (for Research Technician I): The candidate should have a minimum of two years of general laboratory experience, or one year of laboratory experience with molecular biology, or a Bachelor's degree in the biological sciences with relevant laboratory experience in molecular biology that extends beyond coursework to work on a laboratory research project.

 

Must have strong molecular biology skills.

Self-motivated, detail-oriented and very organized.

Ability to work as part of a team.

 

Desired qualifications: Experience with general methods in molecular biology and microbiology, especially the manipulation of DNA, PCR, and DNA sequence analysis.  Experience with sterile technique is critical.  Manual dexterity for setting up assays (“good hands”).  Experience with computers, computer programs such as Word and Excel, and search techniques such as PubMed and BLAST.

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.)

Research Technician I/II, Viral Gene Editing

FH Vaccine and Infectious Disease Division
Category: Laboratory Research Sciences
Seattle, WA, US
Job ID: 13637

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.


This Research Technician I/II position will work on potentially curative genetic therapies for persistent viral infections. The incumbent will be responsible for performing animal studies to validate the potential of newly developed therapeutics in the lab. Responsibilities will include the production and characterization of in vivo grade therapeutics, performance of animal studies, and the analysis of experimental outcomes in blood and tissues. The technician will work under the direction of the Principal Investigator and senior laboratory members, and work independently using discretion and judgment in carrying out experiments.

Responsibilities

The research technician will be required to perform minor murine surgical procedures, including intramuscular, intravenous and intradermal injections, delivery of anesthesia by injection or inhalation, infection with live virus, shaving of fur, blood sampling, and also terminal euthanasia and removal of tissues. Processing of tissue samples for histology and nucleic acid extraction. The technician may be required to assist in the maintenance of a murine colony, which will include breeding and genotyping. Other responsibilities include:

  • Assisting in the production and purification of viral vector stocks required for animal studies including adeno associated virus, lentivirus and adenovirus.
  • Work with supervisor and/or senior lab members in the design of experiments, and will be expected to be responsible for the progress of individual research projects, and to analyze data generated and modify techniques.
  • Identify methodological problems in research protocols and implement modifications to optimize experimental results. Design experiments and develop protocols using techniques including tissue culture, flow cytometry, RNA and DNA extraction, PCR, standard molecular biology methods, tissue sectioning, histology, and immunohisto/cytochemistry.
  • Prepare and present written and oral progress reports concerning studies including assembly, organization, and interpretation of data.
  • Conduct literature reviews and background searches to assist in determining research methods.
  • May perform statistical analyses and manage research database.
  • Work with supervisor to understand project goals and hypotheses.
  • Train other members of staff in techniques.
  • Assist in general maintenance of laboratory including stocking, ordering, maintaining stock and cell lines.
  • The ideal candidate may work on multiple projects (often simultaneously) so should be highly organized, able to multi-task and have a proven ability to work well with others in a team environment.
  • Other duties as required.

Qualifications

Research Technician I required qualifications: Bachelor's degree in a related scientific discipline. Basic laboratory skills and scientific knowledge in the area of study and experience with murine models required.


Research Technician II required qualifications: Bachelor's degree in a related scientific discipline. Intermediate level position requiring 2 years previous experience working in a laboratory and working with murine models.


The ideal applicant will have experience with studies performed in small animals including performing minor surgical procedures. Experience with general methods in molecular biology, histology and tissue culture in a quality-conscious, high-throughput environment. Preference will be given to those with experience in virology. A high level of professionalism and respectful communication with animal health staff are required for this position.

Research Technician II

FH Vaccine and Infectious Disease Division
Category: Laboratory Research Sciences
Seattle, WA, US
Job ID: 13785

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 Taylor laboratory within the Vaccine and Infectious Disease Division is recruiting a Research Technician I/II to perform lab experiments using cutting edge molecular biology and genetic engineering techniques. Preference will be given to candidates with extensive experience in flow cytometry, with knowledge of molecular biology.

Responsibilities

  • Flow cytometry and cell sorting
  • Running of standard assays such as PCR, DNA/RNA isolation, cell electroporation, cell line maintenance, and various in vitro and in vivo lymphocyte assays
  • Collect and analyze data and maintain experimental records
  • Directly execute and drive the implementation of immunological experimental assays
  • May write up an experiment plan, perform and lead experiments, assist in analysis, and provide a report with data interpretation
  • May lead and train other technicians, or team members
  • Responsible for independent work-up and performance of new assays, including literature reviews, experimental design, optimization, troubleshooting, analysis and reporting results
  • Transfer newly developed assays and technologies to other parts of the lab
  • Assist in the design of experiments; may be responsible for the performance of individual research projects
  • May conduct literature reviews to assist in determining most suitable methods to be used in research
  • Identify methodological problems in research protocol and implement modifications to optimize experimental results
  • Prepare and present written or oral progress reports concerning studies including assembly, organization, and interpretation of data
  • May perform statistical analyses, write computer programs, or manage research data base
  • Other duties as assigned

Qualifications

  • MA/MS or BA/BS degree required with preference for biochemistry, immunology or similar areas of focus
  • This is an intermediate level position requiring 2 years previous experience working in a laboratory
  • Preference will be given to candidates with extensive experience in flow cytometry and molecular biology
  • The technician 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 and murine colonies 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
  • Must be flexible and willing to work some evenings and weekends as needed

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 Clinical Programmer

FH Vaccine and Infectious Disease Division
Category: Biostatistics, Bioinformatics and Computational Biology
Seattle, WA, US
Job ID: 14090

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 Programmer to join their team who will provide programming support for data management, reporting, and analysis needs of SCHARP. The Clinical Programmer works in a team environment to support the overall mission of SCHARP. 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 Clinical Programmer shows independence in management of workload and quality output, and provides technical leadership to contribute to the programmatic infrastructure of the Clinical Programming group. The Senior Clinical Programmer may also mentor and/or supervise a junior clinical programmer.

Responsibilities

  • Gather and document requirements for developing or modifying existing programs and systems
  • Define dataset and report specifications
  • Support the protocol study team in the development of case report forms (CRFs) and other study materials
  • Generate, document, and maintain datasets and reports to specification
  • Set up, test and maintain data flows
  • Participate in study closeout procedures
  • Test and de-bug programs and maintain version control on production programs and scripts
  • Test, document, and maintain quality control checks
  • Support development and editing of work instructions and standard operating procedures
  • Provide training and coaching for programming staff

Qualifications

Required

  • Commitment to excellence in public health research
  • Bachelor’s or Master’s degree in a scientific, technical, or health-related field
  • Five years’ experience as programmer in SAS or python
  • 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 in a fast-paced, fast-changing environment

Preferred

  • Experience with clinical trials and data management
  • Experience in programming for scientific research
  • Understanding of good clinical data management practices
  • Experience working with Software Development Life Cycle methods
  • Experience working with CDISC data standards
  • Experience programming in both SAS and python
  • Experience in managing projects or leading teams
  • SAS Certification (e.g. Base, Advanced)

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, 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 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.

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