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.
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Compliance, Audits and IRB/Regulatory Team Management and Oversight
Clinical trials liaison, contract negotiation and implementation
Team Support, Communications, Record-keeping
Project Management, Process Improvement