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.
Join the Bleakley clinical research team and be at the forefront of stem cell transplantation and immunotherapy research. Under the supervision of Principal Investigator Marie Bleakley, MD/PhD, this position is responsible for coordinating research activities and managing data for leukemia patients undergoing transplantation on clinical trials. This role involves primarily responsibilities of a regulatory coordinator and also elements of research coordination, data entry and clinical trial implementation. The successful candidate will perform their responsibilities with a high level of independence and collaboratively within the scope of study protocols and institutional guidelines.
This position works in collaboration with the clinical research nurse and other members of the clinical research team on a set of transplantation protocols studying naïve T cell depletion of peripheral blood stem cell grafts. The patient population includes both pediatrics and adults from around the globe that come to Fred Hutch, SCCA, UWMC and Seattle Children’s Hospital for cutting edge research and treatment. The position includes interaction with the clinical care teams, researchers, and other support staff within and outside of the Fred Hutch/SCCA/UW/SCH system.
The regulatory and research coordinator position will be approximately 60% regulatory, 20% data, 10% implementation and 10% clinical research coordination.
The incumbent works both independently and within a highly collaborative team while performing work assignments, and uses judgment in data monitoring and collection, quality control, co-ordination and liaison activities. Demonstrates initiative and sound judgment in problem solving, providing regulatory guidance and in developing policies and procedures. Has significant interaction with the PI(s), other team members, internal departments and external organizations and agencies.
• Prepare, track and maintain all correspondence and regulatory documentation required by the IRB, FDA 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 files
• Perform internal audit and quality assurance checks on regulatory documents
• With input from PI(s), draft initial clinical research trial informed consent forms
• Assist study start-up: prepare and submit all required regulatory documents for new study applications; successfully open new studies from inception to accrual
• Assist in preparing and presenting materials for monitoring visits
• Assist with 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
• Conduct study close-out
• Process IND external safety reports; maintain documentation of PI review and submit/escalate safety reports as appropriate
• Report non-compliance and unanticipated problems to IRB as applicable
• 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
20% Data, 10% Implementation, 10% Clinical Research Coordinator
• Review and monitor patient clinical trial data
• Maintain protocol databases and ensure timely electronic data capture and review
• Review patient medical records and other related documentation to assist with protocol eligibility determination
• Thorough understanding of all protocol-required monitoring, data collection and reporting requirements
• Monitor patient response to therapy and review for adverse events
• Collaborate with the Clinical Research Nurse to investigate possible protocol deviations and promptly resolve potential clinical concerns
• Monitor adherence to protocol, investigating any violation
• Coordinate research and clinical operations activities to ensure protocol compliance
• Oversee biospecimen tracking and collection of protocol-specific data after patients return to their outside provider
• Organize, coordinate and oversee specimen shipments from outside institutions to the research laboratories
• Assist in the planning and content of reports to the DSMB, IRB, FDA and publications
• Coordinate special projects
• Perform other duties as assigned
• Bachelor's Degree in a related field; relevant experience in lieu of degree acceptable
• 1-2 years' experience in clinical research and/or regulatory, human research protection or related experience
• Demonstrated knowledge of regulatory guidelines (IRB, IACUC, MUA, etc.)
• Knowledge of FDA, GCP, and NIH requirements
• Strong computer skills and experience working with databases
• Strong verbal and written communication skills essential
• Experience in protocol implementation is desirable
• Knowledge of medical terminology preferred