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44 Found open positions

Assistant Director, Research Finance

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

Overview

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


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


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


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

Responsibilities

A. Financial Strategy and Operations

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

B. Team Leadership

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

C. Financial Reporting and scientific related visits/meetings

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

D. Other Duties

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

Qualifications

Minimum qualifications:

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

 

Key skills and abilities

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

Biostatistician

FH Vaccine and Infectious Disease Division
Category: Biostatistics, Bioinformatics and Computational Biology
Seattle, WA, US
Job ID: 14563

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 4 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

Biostatistician II-III, SCHARP

FH Vaccine and Infectious Disease Division
Category: Biostatistics, Bioinformatics and Computational Biology
Seattle, WA, US
Job ID: 14385

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) who will provide statistical support, which may include reviewing protocol drafts, participation on the protocol development team, and assisting the protocol lead statistician in the design of appropriate analyses. The SRA will write statistical analysis plans for protocols and complete the analysis.

Responsibilities

The incumbent works independently designing, developing, coordinating and performing statistical aspects of study design, implementation, and analyses for clinical trials. The incumbent serves as lead on more than one protocol and may provide mentorship to at least one other SRA. The incumbent works well under pressure, has established a positive and productive working relationship with faculty statisticians and/or industry partners and exercises good judgment with defined practices and policies. Technical skills are strong and reliable, and productivity is high demonstrated by attention to detail, compliance with regulations and best practices, and adherence to deadlines.  


Responsibilities may include some or all of the following:  

 

  • Provide statistical analyses in the form of tables, listings, and figures and/or written summaries of study data and results for use in reports, for example, Data and Safety Monitoring Board meetings, scientific papers, or tables in support of a Clinical Study Report for submission. 
  • Review protocol drafts .
  • Participate in describing and defining statistical considerations in study protocols (ex: sample size/power/analysis models) .
  • Participate in the development of statistical analysis plans. 
  • Participate in the development of quality assurance procedures for on-going data collection and analysis, such as establishing edit checks, or HIV endpoint verification. 
  • Participate in the development and verification of randomization lists.
  • Provide input into the development of case report forms. 
  • Collaborate with programmers in production and verification of standard reports. 
  • Coordinate production of statistical reports in accordance with CDISC data standards and guidelines.
  • Assist in the production of supporting CDISC documentation for submissions (Define.xml, Reviewer’s Guides).
  • Participate in protocol team conference calls and meetings. 
  • Provide statistical consultation for research projects. 
  • Archive statistical files and documents. 
  • Evaluate new statistical software packages. 
  • Represent statistical unit at study organizational meetings.  
  • Represent study at scientific meetings.  
  • Give oral presentations of study results.  
  • Assist other statistical research associates with statistical analyses. 
  • Collaborate with internal PhD statisticians/epidemiologists and external subject-matter experts to perform statistical analyses of clinical trials data for production of abstracts and manuscripts. 
  • Perform other responsibilities as required. 

Qualifications

Required:

  • A master's degree in Statistics or Biostatistics or related field.
  • A minimum of three years of experience working in clinical trials.
  • Proficiency in statisitcal computing including SAS and R.
  • Excellent oral and written communication skills.
  • Ability to effectively collaborate with internal and external colleagues in a team environment.

Preferred:

  • Proficiency in programming statistical reports using CDISC data standards.
  • Experience in producing statistical reports in suport of an FDA submission.

 

Clinical Coding Specialist

FH Vaccine and Infectious Disease Division
Category: Clinical Research Support Services
Seattle, WA, US
Job ID: 14677

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.

 

This is a 60% time position at 24 hours per week.

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: 14316

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, they 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. They will be coordinating larger, more complex studies and/or a larger volume of studies with minimal assistance.

  • 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.
  • Effectively manage assigned protocol/study, establish timelines and milestones, monitor and communicate ongoing status and progress.
  • 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.
  • Participate in development of protocol/study from draft protocol to optimize collection of accurate and high-quality data.
  • Work with project sponsors, stakeholders and SCHARP team members to define project requirements, scope, risks, staffing requirements, organization and approach.
  • Act as subject matter expert for data management issues between SCHARP study teams and external domestic and international research sites for assigned studies.
  • Assist in development of Case Report Forms (CRFs) for assigned studies.
  • Assist in the design of the protocol/study specific database for assigned studies.
  • 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.
  • Perform User Acceptance Testing (UAT) for assigned studies.
  • Monitor study data to insure the quality and completeness of the data submitted by implementing quality control procedures.
  • 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 the maintenance of documentation of the study database and other related data management programs and/or applications.
  • Assist in the review of new and revised departmental SOPs and WPGs.
  • Ensure that SCHARP meets its obligations in accordance with Good Clinical Data Management Practices (GCDMP).
  • 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 Trial Assistant / Program Assistant I - Boeckh Clinical Research Team

FH Vaccine and Infectious Disease Division
Category: Clinical Research Support Services
Seattle, WA, US
Job ID: 14584

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 is a full-time position to assist study coordinators with scheduling clinical trial subject appointments, study kit preparation and data entry in addition to performing chart review for research trials in infectious diseases. This unique position will work under the direction of the Senior Clinical Research Manager and the Principal Investigator. The incumbent will perform functions requiring knowledge and skills specific to the program studies and to clinical research. 

Responsibilities

  • Assist the study coordinator with scheduling appointments for subjects on clinical trials, sample tracking and preparing study kits for a large sample collection study.
  • Perform review of medical charts using ORCA/Mindscape and enter data in REDCap, Microsoft Access, Excel or other study-related databases
  • Perform data entry for CRFs and review data prior to entering to ensure its credibility
  • Assemble study kits for clinical trials
  • Assist with basic processing and banking of lab specimens and associated record keeping
  • Assist with retrieving and transporting clinical blood specimens from the UW Medical Center and Seattle Cancer Care Alliance
  • May perform other duties as assigned

Qualifications

Minimum qualifications:

  • BA/BS in a biological sciences field, or Medical Assistant with experience in chart review and scribing
  • Must be competent working with Office Suite, particularly with Excel and PowerPoint. It is expected that the incumbent will be familiar with extracting data from a database and with data filtering
  • Strong written and verbal communication skills.
  • Attention-to-detail is required for the position

 

Preferred qualifications:

  • Previous experience working with patient medical charts
  • Previous work as a medical scribe or similar experience with medical terminology
  • Experience working with REDCap and Access databases

Data Scientist I - Computational Immunology

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

Overview

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

 

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

Responsibilities

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

Qualifications

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

Director, Clinical Data Management

FH Vaccine and Infectious Disease Division
Category: Clinical Research Support Services
Seattle, WA, US
Job ID: 14599

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 Director, Clinical Data Management (CDM) to provide overall leadership and management of the clinical data management and safety teams (consisting of approximately 40 employees) 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. Director, Clinical Data Management will also work closely with SCHARP’s Executive Director, Managing Director and Senior Management Team to create and implement the overall organizational strategic direction, project plans, and initiatives.

Responsibilities

Leadership

  • Provide overall strategic, organizational, and operational management and guidance to the CDM group.
  • Collaborate with the SCHARP Executive Director and other unit Directors to create and implement overall organizational vision and strategic direction.
  • Foster and promote the long-term development of the CDM team, work closely with the SCHARP Executive 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.

Financial Analyst II (Grants and Contracts)

FH Vaccine and Infectious Disease Division
Category: Grants and Contracts
Seattle, WA, US
Job ID: 14418

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 Financial Analyst II position supports the fiscal management operations of the Infectious Disease Sciences (IDS) Program. The position collaborates with internal and external stakeholders and partners including Principal Investigators, program, division and center staff, and sponsor organizations to ensure timely and accurate accounting and financial reporting of sponsored research in compliance with federal and external sponsor regulations and requirements.

 

This position will co-manage the preparation, interpretation and analysis of financial data, and is responsible for the management and administration of sponsored and non-sponsored research project funds.

Responsibilities

The incumbent works with minimal supervision and reports to the Fiscal Manager in the Infectious Disease Sciences Program. The Financial Analyst II (FA) will design, develop, and be responsible for overseeing and managing budget/fiscal systems, policies, and procedures for grant and contract budgets for Principal Investigators and management staff. They are expected to use initiative and sound judgment in carrying out responsibilities within the framework of the appropriate funding source/agencies policies and procedures.

 

They provide highly responsive, efficient support services and has a broad range of responsibilities including: establishes and maintains comprehensive fiscal record keeping systems including: budget monitoring and reporting for grants management, subcontract oversight and special project support in support of the program.

 

This position serves as the liaison for funding issues related to grant, contract, subcontracts, clinical trial budget management and support with an increasing workload for these types of studies in IDS. In this area of responsibility, the FA interprets and ensures compliance with sponsor (federal and industry) guidelines, and maintains and manages study payments and milestones.

  1. Develop and guide cost analysis process by establishing and enforcing policies and procedures; providing trends and forecasts; explaining processes and techniques; recommending actions to PIs and program leadership. Performs professional financial and budget analysis for PIs and program leadership promoting strategic decision-making and fiscal responsibility, using research business metrics to clarify all decision making support optimal decision-making and cost management.
  2. Develop, modify, and maintain multiple record keeping and reporting systems for varied and complex sources of funding. Oversee and co-manage monthly budgets to actual reporting, year-end summary analysis and trend reporting to program leadership and PIs, and analysis of significant variances at a program and project level. Utilize online financial system to monitor budgets and resolve problems. Ensure accuracy and integrity of financial information in the development of complex technical fiscal analysis and financial reporting to multiple sources according to strict guidelines and deadlines. Review project costing classification and integrity of data used in financial reports, proposing resolutions of discrepancies in financial data to management, as needed.
  3. Assist in the annual budget process including analysis of submitted budgets compared to budget targets, preparation of summarization reports and communication of results to program leadership/PIs.


The position focuses on setting up of systems for industry-sponsored studies and working with Principle Investigators (PIs) and clinical research staff to maintain, monitor, track and manage study milestones and payments. Each clinical trial is unique as PIs work with a multitude of industry sponsors and each contract and study is unique based on enrollment criteria/eligibility, milestone tracking (e.g. patient visits, screen failures), complexity of reporting data, and close-out procedures.

  1. Manage/monitor sponsored and non-sponsored research projects funded with restricted contributions and communicate with program leadership/PIs for project approval and set-up, budget monitoring and project close-out. This includes: working closely with teams and sub-awarding institutions on managing sub award setup, billing and payments. Conduct all necessary steps in closing out of expired budgets including cost transfers, salary transfers, and verifying that all sponsor payments have been received.
  2. Oversee accounting for federal sponsored research grants, industry contracts, and other designated funds so that grants and contracts and non-sponsored research projects are managed in accordance with grantor and contractor requirements. Communicate with program leadership/PIs for project approval and set-up, budget monitoring and project close-out. This includes monitoring grant, contract, clinical trial, clinical research, foundation, operational, gift and discretionary budgets to document expenditures and verify proper accountability.
  3. Monitor non-sponsored research projects funded with restricted contributions and communicate with strategic planning initiative research administrators for project set-up, budgeting and close-out.
  4. Perform other financial analysis and special projects as assigned.

Qualifications

  • Bachelor’s degree in accounting or finance preferred.
  • Minimum of 2-5 years of experience in accounting or finance preferred, ideally in a research or not-for-profit environment.
  • Exceptional analytic skills and demonstrated ability to build financial models for business forecasting, variance analysis, and problem solving and providing recommendation based on results to PI and program management for strategic decision-making.
  • Advanced proficiency in Excel (including Pivot Tables), PowerPoint, Access, SharePoint and Word.
  • Experience with Tableau, or similar data visualization tool.
  • Well-developed verbal and written communication skills, including an ability to understand complex problems, to collaborate and explore alternative solutions. Ability to organize thoughts and ideas into understandable terminology.
  • Ability to work independently on multiple projects and communicate status of projects to key decision makers on a proactive basis. Position may require flexible work hours to meet deadlines/deliverables.
  • Exposure to performing grant submissions and accounting or project cost accounting a plus. Familiarity with NIH rules/guidelines.

Fiscal Manager, HVTN

FH Vaccine and Infectious Disease Division
Category: Grants and Contracts
Seattle, WA, US
Job ID: 14491

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) is the world’s largest publicly funded multi-disciplinary international collaboration facilitating the development of vaccines to prevent HIV/AIDS. The HVTN conducts all phases of clinical trials, from evaluating experimental vaccines for safety and immunogenicity to testing vaccine efficacy.


The Fiscal Manager is responsible for coordination of budget and financial activities for the HIV Vaccine Trials Network (HVTN) including the cooperative agreement, supplement and carry-forward requests and many complex subcontracts. Incumbent works under the direction of the HVTN Executive Director and Principal Investigator for the HVTN Leadership Operations Center, referring issues and soliciting guidance as necessary, and coordinating the budget-related work of other staff.

Responsibilities

  • Administer and monitor HVTN budget(s), providing routine reports and projections to management
  • Oversight in managing multiple large, complex multi-year awards from NIH/NIAID, Bill and Melinda Gates Foundation (BMGF), and other funders
  • Provide financial support to HVTN clinical research sites around the world, including annual funding requests and monthly invoice/expense report review
  • Maintain and enhance multiple record keeping and reporting systems for varied and complex sources of funding; develop procedures for implementation, execution, control and review/audit of fiscal operations
  • Responsible for providing clinical trial cost estimate to HVTN Leadership
  • Works collaboratively with the contracts specialists to administer and monitor the HVTN's national and international subcontracts, ensuring deliverables are timely, any contract requirements are observed, and payments are made
  • Serves as a fiscal liaison and participates in cross-network fiscal working groups
  • Liaison to Fred Hutch Office of Sponsored Research, Fred Hutch Finance, and other HVTN sites, providing information as needed for allocation of all funds
  • Assists in the development of project policies and procedures as they relate to budget and contract administration

Qualifications

Minimum qualifications:

  • Bachelor's degree in accounting, public administration, or related field required.
  • Minimum of 8 years’ experience in the financial field with specific experience working with grants and contracts (preferably NIH grants).
  • Experience with large multi-site clinical research organizations and administration of sub-contracts preferred.
  • Experience with detailed financial analysis tools and reporting.
  • Strong computer skills—MS Word, Adobe Pro, and advanced knowledge of Excel required.
  • Excellent written and verbal communication skills.
  • Demonstrated ability to multi-task in a fast-paced fiscal management environment.
  • Demonstrated ability to work effectively in a team environment as well as individually.
  • Ability to problem-solve and process information quickly.
  • Available for periodic travel to HVTN research sites in other countries.


Preferred qualifications:

  • MBA/CPA Preferred
  • Experience working with Uniform Guidance is highly preferred.
  • Experience with Hyperion, PeopleSoft and related databases is preferred.
  • Experience working internationally and/or working with non-U.S. organizations is helpful.

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.

IRB Regulatory Coordinator II - Infectious Disease Sciences

FH Vaccine and Infectious Disease Division
Category: Clinical Research Support Services
Seattle, WA, US
Job ID: 14603

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 Regulatory Coordinator works with faculty and staff in the Infectious Disease Sciences Program in the Vaccine and Infectious Disease Division to ensure all regulatory compliance measures are followed for clinical trials by coordinating regulatory submissions and monitoring as well as assisting with the resolution of compliance issues. 

 

The Regulatory Coordinator works on the Infectious Disease Sciences Program’s IRB and Regulatory team reporting to the team manager/supervisor. The position is expected to work independently within a framework of established regulations and guidelines, and demonstrate initiative and sound judgment in problem solving, providing regulatory guidance and developing policies and procedures. This position has significant interactions with the PI(s), other team members, internal departments and external organizations and agencies. 

Responsibilities

  • Prepare, track and maintain all correspondence and regulatory documentation required by the IRB, FDA, sponsors, and other institutional and federal oversight committees, including drafting and reviewing content as appropriate.
  • Submit all regulatory documents to the IRB and other governing bodies to maintain study compliance with GCP, institutional and federal regulations.
  • Maintain study regulatory binders and electronic files g. SharePoint, OneDrive, OnCore.
  • Perform internal audit and quality assurance checks on regulatory documents.
  • With input from PIs, study team, draft initial clinical research informed consent forms and study documents.
  • Lead study start-up; prepare and submit all required regulatory documents for new study applications; successfully open new studies from inception to accrual.
  • Prepare and present materials for monitoring visits; may serve as primary point of contact during visits.
  • Independently follow-up and resolve all issues related to regulatory concerns identified during monitoring visits.
  • Prepare and submit modifications/amendments, and continuing renewals for ongoing study maintenance in a timely manner.
  • Conduct study close-out. Be responsible for archiving regulatory documents/records, ensuring that all files are prepared for off-site storage in accordance with FDA, other applicable regulatory guidelines and program SOP.
  • Process IND external safety reports, maintain documentation of PI review and submit safety reports to the IRB as appropriate.
  • Report non-compliance and unanticipated problems to the IRB as applicable.
  • Serve as primary regulatory resource for PIs, sponsors, a study team, providing guidance on regulatory statuses, approvals and instructions regarding patient consent.
  • Serve as liaison for internal regulatory bodies (IRB, Clinical Research Support, Regulatory Affairs, etc.)
  • Stay abreast of new impacts/areas of knowledge and regulatory changes and disseminate this knowledge to the study/operations team. Work with IRB team and IDS leadership to develop standard operating procedures (SOPs).
  • Identify, develop and implement any necessary revisions to related policies and procedures.
  • Work with fiscal team/PI/study team regarding funding proposals, annual progress reports.
  • Coordinate and manage the regulatory documents from each participating sites for studies where IDS serves as the IRB of record (coordinating center). Also track sites’ annual continuing reviews and alert sites to upcoming expirations to prevent lapses from occurring.

Qualifications

Minimum qualifications:

  • Associates or Bachelor’s degree and a minimum two years of regulatory, human research protection or related experience in a research environment. 
  • Demonstrated knowledge of regulatory guidelines (IB, IACUC, MUA, etc.), knowledge of FDA, GCP and NIH requirements, ability to interpret and synthesize regulations and guidelines.
  • Ability to adapt and adjust priorities based on changing needs, strong written and verbal communication skills, problem solving skills, and the ability to reach and reconcile data in reports. 
  • Ability to use discretion and maintain confidentiality. 
  • Proficiency with MS Office suite.

Preferred qualifications:

  • Certified IRB Professional (CIP) certification

Intern, Research (Seattle Central College/MESA program applicants only)

FH Vaccine and Infectious Disease Division
Category: Internships
Seattle, WA, US
Job ID: 14590

Overview

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


The Boeckh lab is seeking an undergraduate intern to learn about operations of the Infectious Disease Sciences Biospecimen Repository, a valuable resource that includes more than 300,000 biospecimens spread across 20+ freezers that have been collected over a 40-year period.


The successful candidate will work collaboratively as part of a team to process and add new research samples, maintain and improve organization within the repository and respond to investigator requests. With interest and experience in our lab, the individual may assist with additional opportunities in research. This position offers exposure to faculty and staff across a broad range of careers in clinical and laboratory research and is an excellent opportunity for anyone considering a future in clinical or lab-based research or medicine.

 

Ideal candidates will be available for 10-12 hours per week for an internship that will last 6 months. This position is open only to members of the MESA program at Seattle Central College. Preference will be given to LSAMP eligible applicants. The internship will go for 6 months from Jan – June 2020.

Responsibilities

  • Accurate data management as they help review, improve and maintain inventories of biospecimen collections.
  • Biosafety to ensure protection of worker and samples.
  • Specimen handling (including aseptic technique and proper pipetting) according to a variety of protocols as they process specimens and accession them into the repository, as well as thaw and aliquot samples to fulfill requests.
  • Use of laboratory equipment and proper storage of samples of different types.
  • Project management and prioritization of tasks as they locate and retrieve specimens in response to investigator requests.
  • Developing and answering research questions and they interact with investigators to learn about their research projects.
  • Ethics and policies required to protect subject privacy and autonomy in clinical research.

Qualifications

  • Must have a high school diploma or GED, with an interest in laboratory or clinical research and healthcare
  • Candidates must be enrolled at Seattle Central College and will have completed at least one year of coursework, including basic biology and chemistry
  • Accuracy and attention to detail is essential
  • The ideal candidate will by highly motivated and derive satisfaction from creating order out of disorder.
  • Experience with Microsoft Office Suite (especially Excel and Access) and effective verbal and written communication skills are also desired

This position is open only to members of the MESA program at Seattle Central College

Lab Aide (Work Study)

FH Vaccine and Infectious Disease Division
Category: Laboratory Research Sciences
Seattle, WA, US
Job ID: 14486

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 lab, within the Vaccine and Infectious Disease Division, is recruiting a as Work Study Lab Aid I to perform general lab duties, including mouse colony maintenance, cell culture, and assisting others in the lab with experiments. Candidate must be willing to work with/handle murine, as well as human tissues under carefully controlled conditions.

 

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

Responsibilities

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

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

Qualifications

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

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

Lab Aide (Work Study)

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

Overview

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

Responsibilities

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

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

Qualifications

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

 

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

Lab Data Coordinator

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

Overview

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

 

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

Responsibilities

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

 

Responsibilities may include:

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

Qualifications

Minimum Qualifications

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

Lead Data Standards Analyst

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

Overview

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

 

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


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

Responsibilities

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

Qualifications

Minimum qualifications

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


Preferred qualifications

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

Lead Software Development Engineer

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

Overview

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

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

Responsibilities

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

Qualifications

Minimum: 

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

  

Preferred: 

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

 

Culture: 

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

Post-Doctoral Fellow/Research Associate, Protein Engineering (dCas9) for Microbial Epigenetics

FH Vaccine and Infectious Disease Division
Category: Post-Doctoral Research Fellows and Associates
Seattle, WA, US
Job ID: 14462

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 Johnston Laboratory in the Vaccine and Infectious Disease Division at the Fred Hutchinson Cancer Research Center is recruiting a highly motivated and creative Post-Doctoral Fellow/Research Associate to conduct research relating to microbial epigenetics, metagenomics and synthetic microbiology. The successful candidate will be involved in multiple funded projects that seek to create new technologies (dCas9 effectors) and methodologies to delineate and/or engineer the epigenetic landscape of the human microbiota. These projects will focus particularly on microbial communities that reside within human tumors and related clinical cancer specimens.


We are accepting applications from both recent graduate students and more senior post-doctoral fellows with 2-3 years’ of post-doc experience that may be suitable for a Research Associate track.

Responsibilities

The Johnston Laboratory is an interdisciplinary and highly collaborative team of classically trained microbiologists, synthetic microbiologists, bioinformaticians and engineers. Using cutting edge technologies and methodologies, we seek to gain a deeper functional understanding of what bacteria are doing and how they are doing it. We then use that information to create novel therapeutics and engineer the next generation of microbe-based technologies for application in human medicine, synthetic microbiology and bioengineering.


Wet-lab: The ideal candidate must have extensive wet-lab experience in current synthetic biology/molecular biology techniques for protein engineering and purification (CRISPR-Cas/dCas9-effector engineering, purification and validation). Hands-on experience with human/microbial DNA methyltransferase enzymes would be advantageous and complementary to current projects. Experience with immunoprecipitation-based strategies for enrichment of DNA from complex specimens is a plus, but not required.


Dry-lab: The candidate should have computational expertise in software tools for molecular modeling and simulation software, familiarity with the protein modeling and design (e.g. Rosetta software/BioRender/Pymol), protein docking modelling, and an understanding of enzyme/protein structure-function relationships. Dry-lab experience with Linux-based bioinformatic software / data analysis environments (Python/R) is favorable. Familiarity with handling DNA/RNA sequencing data and related programs will be advantageous.

Qualifications

Please include a cover letter with your application, detailing your interest and suitability for this position.

 

 

Post-doctoral Fellow minimum qualifications:

  • Ph.D. in Bioengineering, Protein Biochemistry, Molecular biology, or a related field

Research Associate minimum qualifications:

  • Ph.D. in Bioengineering, Protein Biochemistry, Molecular biology, or a related field
  • Must have completed a minimum of 3-4 years as a post-doctoral fellow
  • Must have proven track record of high-quality peer-reviewed publications, including first-author publications are required
  • Appointment at this rank requires pre-approval of the Vaccine and Infectious Disease Division Director

Other Competencies/Qualifications:

  • Proven expertise with wet-lab synthetic biology techniques for protein engineering, ideally with a focus on dCas9 effectors
  • Molecular modeling and simulation software, familiarity with the protein modeling and design (e.g. Rosetta software/BioRender/Pymol) protein docking modelling, and an understanding of enzyme/protein structure-function relationships
  • Candidate must demonstrate outstanding personal initiative and creativity in problem solving
  • Excellent written and oral communication skills are required for manuscripts/grants preparation, public presentation, and collaboration with other researchers
  • Experience with effectively mentoring junior researchers is preferred
  • Experience with statistical analysis.
  • Excellent teamwork, time management and organizational skills
  • Ability to work independently in a dynamic and results-oriented environment
  • Ability to meet deadlines and multitask efficiently is a must

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- 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- Single-Cell Bioinformatics

FH Vaccine and Infectious Disease Division
Category: Post-Doctoral Research Fellows and Associates
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-Jerome Lab

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

Overview

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

Responsibilities

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

Qualifications

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

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

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

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

Overview

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

 

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

Responsibilities

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

Qualifications

Required:

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

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

Post-Doctoral Research Fellow: HIV-1 Vaccine Development

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

Overview

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

 

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

Responsibilities

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

Qualifications

Required:

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

Preferred:

  • Expertise in B cell immunology is highly desirable

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

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

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

Overview

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


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


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

Responsibilities

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


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

Qualifications

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

 

Required qualifications:

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

Preferred qualifications:

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

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 II, HVTN Laboratory Operations

FH Vaccine and Infectious Disease Division
Category: Quality
Seattle, WA, US
Job ID: 14450

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 II is to provide oversight, coordinate and facilitate clinical site specimen processing and clinical testing lab projects and programs for the HVTN Laboratory Operations Division. QA Associate I vs. II designation will be based on candidate’s qualifications and related experience.

 

The QA Associate will provide QA oversight to processing labs associated with HVTN clinical trials by:

 

  • Providing oversight for domestic and international network site labs for HVTN study preparation: providing site training, developing and communicating study-related lab practices and operations, and determining network lab equipment needs. The QA Associate will monitor Good Clinical Laboratory Practice compliance, workload, and other key quality indicators that may impact deliverables.
  • Providing input and support to other divisions within the HVTN and client protocol teams for specimen processing, storage and shipping, as well as clinical lab testing/methodologies.
  • Facilitating implementation of specimen management programs for study related specimens including data entry and electronic systems support.
  • Providing oversight for specimen processing and cryopreservation training and certification program.
  • Providing peripheral blood mononuclear cell (PBMC) External Quality Control program support including analysis, interpretation and reporting to sites.  Review adequacy of site response on EQC reports.
  • Create additional quality assurance programs for other specimen types.
  • Collaborating with other divisions within the HVTN to support network clinical trials and representing the HVTN Lab Center in interactions with stakeholders.
  • Providing network lab support and training through regular site visits, conference calls, or other appropriate media. Must be able to adapt communication styles based on targeted audience and topic.
  • Assisting site labs with implementation of individualized Quality Assurance plans and related QA systems, such as local document control and equipment maintenance programs.
  • Coordinating, participating in, and supporting the efforts of the HVTN Laboratory Program and performing additional activities as necessary.

Qualifications

Minimum qualifications

  • B.A./B.S. 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
  • Ability to work with minimal supervision

Preferred qualifications

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

QA Associate II, HVTN Laboratory Sciences

FH Vaccine and Infectious Disease Division
Category: Quality
Seattle, WA, US
Job ID: 14449

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 Quality Assurance (QA) 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, Seattle Research & Development, and Specimen Processing Laboratories. The incumbent will work under the direction of the HVTN Lab QA Program Manager. QA Associate II designation will be based on candidate’s qualifications and related experience.

  • Conduct internal laboratory audits to ascertain that all activities conform to Good Clinical Laboratory Practices (GCLP) guidance. Host external (e.g. study sponsor) audits, facilitating audit related interviews with internal subject matter experts and laboratory leadership.
  • Formally document internal audit findings and report to HVTN Laboratory Program Director. Coordinate laboratory efforts in responding to external audit findings; compile replies in appropriately formatted responses.
  • Facilitate compliance issue resolutions and incident management with laboratory leadership and staff, as appropriate. Provide recommendations and communicate status of action resolution; track corrective actions for effectiveness.
  • Maintain electronic QA systems (e.g. document control). Coordinate/participate in efforts related to implementation of new electronic QA systems as required.
  • Audit final study reports to ascertain that the report reflects the raw data of the study.
  • Monitor and maintain electronic and hard-copy archives of source documents in compliance to GCLP guidance.
  • Assess clarity, adequacy, and GCLP-compliance of new and revised operational standard operating procedures (SOPs); maintain related document control.
  • Facilitate internal and external proficiency/quality assurance investigation and corrective actions for any unacceptable results.
  • Work collaboratively with the HVTN Central Quality Assurance Program. Interact with QA mangers at other similar network laboratories to help ensure compliance with HVTN procedures/conventions and DAIDS GCLP guidelines.
  • Support quality assessment and improvement activities for the network; provide consultative services as appropriate.

Qualifications

Minimum Qualifications

  • BS or MS degree in an appropriate scientific field.
  • Familiarity with regulatory requirements for laboratory-performing clinical studies
  • Minimum 5 years of experience working in a GCLP, GLP and/or GMP regulated setting

Preferred qualifications

  • Membership/certification in SQA (Society for Quality Assurance) strongly preferred
  • Familiarity with cellular immune monitoring techniques
  • Experience in immune monitoring of vaccine clinical trials or vaccine development
  • Experience in validation of biological methods

Research Administrator II (Grants and Contracts)

FH Vaccine and Infectious Disease Division
Category: Research Administration & Faculty Affairs
Seattle, WA, US
Job ID: 14454

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 Research Administrator II is responsible for designing, developing, evaluating and interpreting financial information systems and budget/fiscal policies and procedures for faculty and management in Infectious Disease Sciences Program related to federal grant and contract management. The incumbent will perform complex technical fiscal analysis and financial reporting including planning and interpreting policies and regulations.


Under general direction, this position performs a variety of complex operating, capital budget or fiscal administrative support functions such as analyzing and developing budgets for grants, contracts, state funds, and program funds; assisting in the development of financial/fiscal policies; identifying project expenditure/revenue patterns; preparing analyses in support of program plans and budget requests; evaluating financial alternatives and recommending appropriate action; establishing and maintaining comprehensive fiscal record keeping systems; and recommending or implementing changes to fiscal information systems.

Responsibilities

Budget/Fiscal Support

  • Develop, modify, and maintain multiple record keeping and reporting systems for varied and complex sources of funding; develop procedures for implementation, execution, control and review/audit of fiscal operations
  • Develop, recommend, and/or establish expenditure forecasting for self-sustaining accounts; forecast fiscal needs/commitments; analyze policies and project fiscal impact
  • Prepare budget projections, reconcile expenditures, and monitor the payroll changes.
  • Analyze, modify and recommend improvements in subsidiary and general fiscal record keeping systems; apply knowledge of accounts and program relationships, data flow, audit trails and internal controls to design and implement financial data systems
  • Select, develop, implement and/or modify manual or automated fiscal reporting/tracking processes to address specific unit needs

Funding Source Administration

  • Work closely with Principal Investigators to develop budgets for grants, contracts, or other funding requests; prepare appropriate forms for contracts and agreements as needed.
  • Coordinate and review all applications submitted for grant and contract funding.
  • Secure the necessary signatures for grant and contract applications, and tracks approval process from beginning to submission to ensure that all the necessary permissions are documented prior to the grant/contract deadline.
  • Consult with funding agencies to resolve problems and/or obtain approval for deviation from authorized procedures or expenditures; advise and assist organization's staff regarding budgetary policies and procedures, account status
  • Anticipate, coordinates and plans for all competing and non-competing reports/submissions. 

Regulatory Support

  • Manage renewal timelines and ensure completion of regulatory documents in conjunction with IRB team for competing and non-competing reports/submissions.
  • Identify necessary regulatory components of submissions, confirm with IRB team that required items are in place and escalate issues as needed.
  • Determine impact of and develop implementation plans with IRB team in response to applicable regulatory changes and/or revisions to Center policies and procedures
  • May serve as a central point of contact to answer questions, escalating issues as needed.

Administrative Support

  • Complete or delegate key administrative tasks such as travel coordination, editing CVs and publications, purchasing and maintenance of supplies and equipment
  • Identify administrative issues for discussion with leadership
  • Assist with the development of lower level staff
  • May manage projects including occasional event planning and management
  • May assist in the training and development of team members

Leadership

  • May act as a resource for lower level staff

Clinical Trials Addendum

  • Manage budget based on protocol (Core)
  • Set up and pay bills to third parties (Core)
  • Ensure regulatory documents are in place (CT)
  • Responsible for Clinical Trials Billing including the creation of payment invoices.  
  • Tracking and Auditing of procedures to ensure compliance (CT)
  • Amend budget through the life of a study (Core)
  • Attend study implementation meetings as needed (CT)
  • Manage multi-site components (sub-awards) (Core)

Qualifications

  • Bachelor's degree in Accounting, Public Administration, or related field
  • At least 2 years of work experience building, overseeing, and managing budgets
  • Excellent written and verbal communication skills
  • Strong computer skills—MS Word, Access, Adobe Acrobat and advanced knowledge of Excel required.
  • Demonstrated ability to multi-task in a fast-paced fiscal management environment
  • Ability to adjust work-hours to meet grant deadlines, as needed
  • Demonstrated ability to work effectively in a team environment as well as individually
  • Ability to problem-solve and process information quickly with a high attention to detail
  • Previous work experience in grants and contracts field is preferred

Research Technician I - Microbiology/Bacterial Transformation

FH Vaccine and Infectious Disease Division
Category: Laboratory Research Sciences
Seattle, WA, US
Job ID: 14581

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 Johnston Laboratory is an interdisciplinary and highly collaborative team of classically trained microbiologists, synthetic microbiologists, bioinformaticians and engineers. Using cutting edge technologies and methodologies, we seek to gain a deeper functional understanding of what bacteria are doing and how they are doing it, and then to use that information to create novel therapeutics and engineer the next generation of microbe-based technologies for application in human medicine, synthetic microbiology and bioengineering.

Responsibilities

The Johnston Laboratory in the Vaccine and Infectious Disease Division at Fred Hutch is recruiting a highly motivated and resourceful research technician with expertise in the genetic engineering/transformation of non-model bacterial species and general microbiology to join our cutting-edge microbial genomics efforts.

 

The position is intended to provide support for our ongoing microbial engineering projects and microbial technology developments, as well as supporting general laboratory responsibilities. The successful candidate will work with the PI and post-doctoral fellows using state-of-the-art approaches in synthetic microbiology and genomics in a highly collaborative, stimulating, and collegial research environment. The candidate will also assist in lab maintenance, including responsibility of ordering lab reagents/supplies and making of communal lab reagents. With interest and experience in our lab, the individual may assist with additional opportunities in research. This position will provide ample opportunities for professional development and the acquisition of cutting-edge skills in synthetic microbiology research, research planning and strategy, and data analysis and interpretation. The Johnston lab especially encourages those from backgrounds poorly represented in STEM fields to apply to the lab. Specific duties may include:

  • Aerobic and anaerobic bacterial culture and stock maintenance, genetic engineering/transformation of the such strains.
  • Adhere to standard operating procedures (SOPs) for isolation and analysis of DNA and RNA from microbial specimens, including PCR, quantitative PCR, RT-PCR, and sequencing.
  • Maintenance of general lab supplies, consumables and equipment
  • Conduct diligent record-keeping and reporting
  • Ordering/cataloging of laboratories supplies and reagents
  • Presenting findings at internal (Johnston Lab) meetings
  • Other research or organizational duties, as appropriate

Qualifications

Please include a cover letter with your application, detailing your interest and suitability for this position.

 

Minimum qualifications:

  • Bachelor's degree with 1-2 years’ experience in microbial research setting
  • Highly-motivated individual interested in a career in biological research or medicine, with a keen interest in genetic engineering of microbes
  • Technically meticulous when conducting experiments
  • Highly organized in record-keeping
  • Independent, intellectually passionate and able to display scientific initiative
  • Excellent teamwork, time management and organizational skills
  • Ability to work independently in a dynamic and results-oriented environment
  • Ability to meet deadlines and multitask efficiently is a must

 

Preferred qualifications:

  • Basic molecular biology and microbiology techniques, such as aseptic technique, bacterial isolation and culture, strain library maintenance, PCR, DNA/RNA/protein extraction, cloning, recombineering, etc. are stringently required.
  • A working knowledge and previous wet-lab experience with transformation of non-model bacterial organisms (optimization of competent cell preparation/heat shock/electroporation), in addition to standard coli transformations, is highly desirable and preferred.
  • Experience in the design and use of reagents for DNA cloning and genome engineering with shuttle vectors, suicide-vectors, CRISPR/Cas9 and transposon mutagenesis technologies also desirable.
  • Working knowledge and experience in anaerobic culture (anaerobic chamber use) will be beneficial to the role.

Research Technician I-II - X-Ray Crystallography

FH Vaccine and Infectious Disease Division
Category: Laboratory Research Sciences
Seattle, WA, US
Job ID: 14542

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 Stamatatos/Pancera lab, within the Vaccine and Infectious Disease Division, works towards the development of safe and effective vaccines against HIV-1 and malaria. Our major emphasis is the design of protein immunogens and understanding the immune response following vaccination or natural infection. The subgroup led by Dr. Pancera focuses on structural characterization of these immunogens and their immune responses. The laboratory utilizes a wide range of in vitro and in vivo systems and cutting-edge technologies and techniques. Experimental approaches include high-throughput crystallography, specialized immunological methodologies and assays, molecular and cellular biology techniques, bioinformatics, and computational approaches.


Our lab is seeking an outstanding Research Technician I-II to work on a project involving the characterization of the humoral immune response following vaccination against HIV, malaria or other pathogens using X-ray crystallography and cryoEM and the designs of novel immunogens.

Responsibilities

  1. Responsible for crystallization of the proteins/antibodies complexes and for solving and refining their structures
  2. Conduct protein expression and purification experiments, including affinity purification, Ion exchange and FPLC, related to the production of antibodies against viral glycoproteins for structural biology
  3. May involve use of Electron Microscopy, molecular modelling or structure-based mutagenesis and design
  4. May involve use of Bio Layer interferometry, SPR and ELISA
  5. Initiate and carry out scientific projects, under the supervision of Dr. Pancera
  6. Develop and demonstrate a thorough understanding of the scientific literature relating to the research topics.

Qualifications

The ideal candidate must be a ‘risk taker’, show initiative, willingness to take up new skills and responsibilities, and be a team player. Excellent attention to details and the ability to work independently are essential to success in this position, as are good communication and organizational skills. The candidate must be self-motivated, able to multitask and to work within a very collaborative environment. Candidates with backgrounds in areas such as virology, protein biochemistry, vaccine development are strongly encouraged to apply.

 

Required:

  • BS with 1-2 years of experience or MS is required
  • Significant expertise in X-ray protein crystallography highly preferred
  • On-hands experience with diverse aspects of Molecular Biology

Preferred:

  • Knowledge of Cryo-EM
  • Experience in X-ray crystallography including up-to-date knowledge of relevant programs including CCP4, and Phenix packages, protein purification, protein characterization, and a strong publication history
  • Expertise with tissue culture and immunological assays

Research Technician II- Genetic Engineering

FH Vaccine and Infectious Disease Division
Category: Laboratory Research Sciences
Seattle, WA, US
Job ID: 14427

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 II to perform lab experiments using cutting genetic engineering techniques. Preference will be given to candidates with extensive experience using CRISPR/Cas9 or other genetic engineering approaches in primary cell types.

Responsibilities

  • Running of standard assays such as PCR, DNA/RNA isolation, cell electroporation, cell line maintenance, and various in vitro and in vivo lymphocyte assays
  • Multicolor Flow cytometry and cell sorting
  • Flow jo data analysis
  • Design of primers and cloning strategies
  • 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
  • 1 year of genetic engineering experience required
  • Must have experience with multicolor flow cytometry and flow jo data analysis
  • Preference will be given to candidates with extensive experience in multicolor flow cytometry, molecular biology and genetic engineering
  • 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


Research Technician II minimum qualifications - Intermediate level position requiring at least 2 years previous experience working in a research laboratory and BA/BS. Independent research experience outside of laboratory course work is necessary.

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

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 Project Manager, Clinical Trials/Clinical Research Compliance

FH Vaccine and Infectious Disease Division
Category: Clinical Research Support Services
Seattle, WA, US
Job ID: 14604

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.


We seek a Senior Project Manager with strong clinical research knowledge/background, audit coordination and facilitation skills, and the ability to manage multiple projects for the Infectious Disease Sciences' clinical trials/clinical research compliance activities. This individual reports to the Program Operations Director of the Infectious Disease Sciences (IDS) Program, oversees IRB/Regulatory processes and activities in IDS and serves to enhance our compliance activities in order to support the overall development and growth of the IDS Program’s clinical research contracts and clinical trials.

 

The role will help drive projects and bring value through activities including research of applicable rules and procedures, managing and monitoring quality systems within the Program, and maintaining a current working knowledge of applicable regulations and standards. The ideal candidate will be responsible for managing the program’s IRB/Regulatory team, developing a deep understanding of Good Clinical Practices, Human Subjects, FDA and NIH processes, reviewing and updating standard operating procedures, coordinating systems audits and audit follow-up, facilitating external inspections and study visits, and monitoring contract milestones and customer service issues.

 

For more information about the work of Infectious Disease Science, click here: 

https://www.fredhutch.org/en/research/divisions/vaccine-infectious-disease-division/research/infectious-disease-sciences.html

Responsibilities

Compliance, Audits and IRB/Regulatory Team Management and Oversight

  • Manage Program’s IRB/Regulatory staff by facilitating and supporting regulatory, human research protection and related activities in a dynamic clinical research environment, and by enhancing and applying knowledge of regulatory guidelines (IB, IACUC, MUA, etc.), and knowledge of FDA, GCP and NIH requirements.
  • Be the primary Program lead for Fred Hutch’s CTMS systems.
  • In conjunction and support of the Fiscal team, the various clinical research teams and study PIs, conduct contract reviews and assessments of collaborative and sponsorship activities, work products, and deliverables that includes identification of potential risks and recommendations for mitigation.
  • Help to ensure laboratory and research services are in compliance with study protocols and approved SOPs.
  • Be responsible for internal audits and be the primary contact for sponsor and regulatory agency audits. Lead, prepare and participate in on-site regulatory audits and inspections.
  • Prepare written records of all inspections and audits, including protocol/plan, and SOPs.
  • Have a comprehensive and disciplined approach to risk management and regulatory compliance through an intimate understanding of processes and systems, a network of appropriate contacts, and an in-depth knowledge of the internal operations as well as basic understanding of the requirements and systems of the FDA, other government agencies, and sponsorship organizations.

 

Clinical trials liaison, contract negotiation and implementation

  • Be the primary Program lead in clinical trials/clinical research contract negotiations.
  • Assist in tracking and managing all contracts through the contract lifecycle, including drafts, modifications, executions, amendments and renewals. Prepare contract briefs to assure proper interpretation of the contract.
  • Manage selected VALUE contracts and assist with close-outs. Disseminate contractual information as appropriate.
  • Facilitate responses to cost/pricing bids for selected clinical trial studies, proposals and contract negotiations including doing initial reviews of contract terms and requirements, to ensure compliance with all laws and regulations and policies and procedures.
  • Audit existing contracts and oversee contract modifications.
  • Coordinate with Business Development and PI teams to provide strategic input on contracting opportunities and assist in the development, population, and maintenance of an in-house contract management system.

 

Team Support, Communications, Record-keeping

  • Provide staff supervision to the IRB/Regulatory functional team of the IDS Program by planning and overseeing their training, performance, assignment of work and professional development to advance the Program’s regulatory operations.
  • Contribute to a positive and productive work environment through effective collaboration with cross functional units.
  • Proactively develop relationships with, establish goals in collaboration with and have regular touchpoints with key internal stakeholders including clinical, research and business development, Program and PI teams.
  • Work with clinical research study teams, fiscal and lead regulatory staff to ensure timely delivery of contract administration milestones.
  • Develop and support established records management procedures.
  • Assist in the development, maintenance and monitoring of program reports, key performance indicators, forms and templates.
  • Effectively communicate with contracted agencies, partners and stakeholders.

 

Project Management, Process Improvement

  • Organize and promote Program-wide quality system improvement efforts.
  • Update and review standard operating procedures, work instructions, forms and templates as required.
  • Participate in process improvement activities including assessing current processes, providing improvement input and implementing changes.
  • Work closely with clinical research teams to provide expert compliance and regulatory information, manage identified issues, and support continuous improvement.
  • Manage other related projects as assigned by Program Operations Director.

Qualifications

Required

  • Bachelor’s Degree;
  • 5+ years of related experience in human subjects research, contract management/auditing, clinical trial management, project management and/or quality compliance role in the pharmaceutical/biotechnical industry or medical research environment strongly desired.
  • Extensive experience interpreting federal regulations, applying sponsor guidelines, policies and practices and complex sponsor requirements and recommending actions and resolving complex issues.
  • Possesses thorough knowledge of the Good Clinical Practice (GCP) guidelines and the applicable FDA and ICH regulations for conducting clinical
  • Familiarity with basic contract law and standard legal forms and analytical reasoning desired.
  • Self-starter with excellent verbal, written, presentation, and interpersonal communication skills and ability to work with internal and external sources to understand what action is needed to obtain all required documentation.
  • Proven interpersonal skills with the ability to work collaboratively as a member of cross-functional teams, and ability to establish and maintain effective working relationships.
  • Proficiency with designing tools and working with electronic systems used to manage clinical trial data or safety reporting.
  • Must have mature and professional communications skills, strong independent time management skills and the ability to multi-task.
  • Demonstrated ability to maintain confidentiality.

Preferred

  • Master’s Degree in health care related field
  • Working knowledge of regulatory guidelines and expertise in quality for the advancement of therapeutics through different phases of development.
  • Clinical research and compliance, PM certification

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

Staff Scientist: Vaccine Development

FH Vaccine and Infectious Disease Division
Category: Laboratory Research Sciences
Seattle, WA, US
Job ID: 14593

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 a Staff Scientist to assist with the development, validation, and testing of novel vaccine candidates aimed at preventing HIV-1, and Epstein-Barr virus.

Responsibilities

The candidate will design, conduct and analyze immunogenicity and challenge studies in animal models, perform data analysis, prepare reports/manuscripts, and supervise lab staff and related activities. Assignments will be project oriented where goals are long term, rather that experiment oriented. The candidate will work independently and supervise research technicians and assist graduate students as needed.

Qualifications

Required:

  • PhD in immunology, or a related field
  • 5+ years and expertise of postdoctoral, or comparable practical experience
  • Proven track record of publication and written communication skills.
  • Experience with murine models including husbandry, immunizations, bleeds etc.
  • Design and analysis of multicolor flow cytometry panels (>10 colors)
  • Strong molecular biology background

Preferred:

  • Expertise in B cell immunology is highly desirable
  • FACS highly desirable
  • Experience generating mixed bone marrow chimeras and/or performing adoptive transfers
  • Additional experience with non-human primate models

Must be willing to work flexible hours as needed. The candidate must be independent, show initiative, willingness to take up new skills and responsibilities, and be a team player. Excellent attention to detail and the ability to work independently are essential to success in this position. The candidate must be self-motivated, able to multitask and to work within a very collaborative environment.

Technical Project Manager II

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

Overview

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


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

Responsibilities

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


Responsibilities include:

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

Qualifications

Minimum Qualifications

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

Preferred Qualifications

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

Vaccine Trials Project Manager II

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

Overview

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


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


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


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

Responsibilities

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

 

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

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

Qualifications

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

 

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

 

SPECIFIC SKILLS

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

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