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 Hutchs 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 nations first cancer prevention research program, as well as the clinical coordinating center of the Womens Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.
At Fred Hutch, we believe that the innovation, collaboration, and rigor that result from diversity and inclusion are critical to our mission of eliminating cancer and related diseases. We seek employeeswho bringdifferent and innovativeways of seeing the world and solving problems.Fred Hutch is in pursuit of becoming an antiracist organization.Weare committed to ensuring that all candidates hired share our commitment to diversity,antiracism, and inclusion.
The Research Project Manager is responsible for the data management and regulatory operations of the Stephanie Lee Research Group . Manages all database development, systems maintenance and support for multi-site clinical trials. Responsible for preparing and managing regulatory documentation for industry sponsored, investigator initiated and national cooperative group clinical studies.
This position requires understanding of oncology research protocols and translation of the research needs into appropriate data and regulatory requirements. Develops policies, procedures, research instruments, and methods in support of a significant number of complex projects. Supports compliance with data and regulatory documentation requirements for the conduct and sponsorship of NIH and FDA-regulated studies.
This individual will work under the supervision of the Principal Investigator, will report regularly to the PI on study progress, and will be required to perform their responsibilities with a high level of independence within the scope of study protocol(s) and institutional guidelines.
The Manager will apply advanced REDCap programming expertise and management skills in the design and implementation of database systems. The Manager utilizes judgement and skill in coordinating data extraction from medical records. The Manager supports prospective and retrospective projects providing researchers with data for analysis of treatment and outcomes in hematopoetic stem cell transplant patients.
This position is required to use judgment, leadership, and expert knowledge of the academic clinical trial healthcare data and regulatory operations. The position will liaise with study investigators, research staff, numerous UW, SCCA, and FH departments, federal agencies, and industry partners.
Project Management responsibilities:
Monitor project goals and timetables, ensuring that all research and administrative activities are completed.
Serve as project/study liaison, representing the project/study to other Center departments, funding sources, affiliated individuals or institutions, and outside organizations.
Carry-out complex research responsibilities in support of project/study, requiring advanced related education and/or experience.
Develop, interpret, and administer project/study policies and procedures according to protocol, IRB, grant/contract and Center specifications.
Plan and attend Consortium meetings, distribute agendas and study information, take minutes, monitor activities to ensure objectives have been met within designated time frame, and
coordinate follow-up activities.
Data Management responsibilities:
Develop, review, edit, and revise research materials which may include questionnaires, laboratory manuals, operation manuals and educational materials.
Assist the Principal Investigator in the design and implementation of REDCap databases, data collection tools, case report forms, and data cleaning/query programming for multi-site clinical trials.
Develop and implement procedures to ensure accuracy and quality of programs and applications supporting repository data and samples from creation through implementation. Coordinates sample shipments and manifests across all repositories.
Manage Material Tranfer Agreements, Data Use Agreements, and Collaboration Agreements in support of multi-site repository protocols.
Prepare regulatory reports including DSMB materials, IND and FDA reports, and contribute to NIH reports when study data need to be aggregated/presented.
Oversee cleaning of study databases at regular intervals and coordinate annual updates of previous research cohorts.
Work closely with biostatisticians to check and correct data elements
Regulatory Coordination responsibilities:
Prepare, track, and maintain all correspondence and regulatory documentation required by the Institutional Review Board (IRB), FDA, and other institutional and federal oversight committees.
Prepare or assist in preparing initial IRB applications, continuation review reports, and protocol modifications.
Coordinate submission of new investigator-sponsored IND applications to the FDA, and draft non-technical portions of IND applications. Support development, review, and maintenance of protocol-specific and IND-specific documents and procedures.
Oversee, coordinate and ensure compliance with ongoing reporting requirements including IRB and FDA initial protocol/IND submissions, annual reports, study amendments, safety reports, and unanticipated problem/noncompliance reports. This includes submissions to all institutional governing bodies as applicable, including but not limited to the Scientific Review Committee, Institutional Review Board.
With input from the PI, draft initial clinical research trial consent forms in accordance with CFR, FDA, and institutional guidelines, ensuring inclusion of all appropriate Elements of Informed Consent. Translate complicated research protocol requirements into language easily understood by research participants.
Maintain regulatory binders including the update of all required regulatory documents (e.g. FDA form 1572 and/or 1571, signature pages and letters of acknowledgement, investigator brochure, financial disclosure forms, laboratory accreditations, laboratory reference ranges, investigator and research staff CVs, medical licenses, and related forms) per sponsor, federal, and institutional requirements.
BA/BS in related field required. MA/MS desired.
Minimum of three years post-master's or five years post-bachelor's related project/study management experience in a clinical research setting, ideally with front-line experience in coordinating therapeutic and observational studies.
This position requires excellent organizational skills, attention to detail, ability to solve problems and to prioritize multiple competing tasks in a dynamic environment.
Collaborative focus is essential, as well as strong written and verbal communication skills.
The successful candidate must understand our ongoing studies in order to successfully support the data and regulatory needs of each study.
Applicants must include a cover letter to be considered.
A statement describing your commitment and contributions toward greater diversity, equity, inclusion, and antiracism in your career or that will be made through your work at Fred Hutch is requested of all finalists.
Our Commitment to Diversity
We are proud to be an Equal Employment Opportunity (EEO) and Vietnam Era Veterans Readjustment Assistance Act (VEVRAA) Employer. We are committed to cultivating a workplace in which diverse perspectives and experiences are welcomed and respected. We do not discriminate on the basis of race, color, religion, creed, ancestry, national origin, sex, age, disability (physical or mental), marital or veteran status, genetic information, sexual orientation, gender identity, political ideology, or membership in any other legally protected class. We are an Affirmative Action employer. We encourage individuals with diverse backgrounds to apply and desire priority referrals of protected veterans. If due to a disability you need assistance/and or a reasonable accommodation during the application or recruiting process, please send a request to our Employee Services Center at [email protected] or by calling 206-667-4700.
At Fred Hutchinson Cancer Research Center, teams of world-renowned scientists and humanitarians work together to prevent, diagnose and treat cancer, HIV/AIDS and other diseases. Researchers are discovering new ways to detect cancers earlier, improve treatments, and learn how to prevent cancers from growing. Although Fred Hutchinson opened its doors in 1975, its history began about 20 years before that. In 1962 Fred Hutchinson envisioned a center devoted to studying cancer, a disease that took his brother’s life. Today Fred Hutchinson is contributing to the next waves of breakthrough treatments and prevention strategies. Fred Hutchinson collaborates with the Seattle Cancer Alliance, the National Cancer Institute, and the University of Washington.