Regulatory Operations Manager, Oncology Clinical Trials

Fred Hutchinson Cancer Research Center

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.

The Regulatory Operations Manager will be responsible for growing and overseeing a team that manages the day-to-day regulatory documentation of intervention oncology clinical trials, including investigator-initiated trials, multi-site IND trials, NCI National Clinical Trial Network (NCTN) trials (cooperative group clinical trials) and industry-sponsored trials. The position will manage all aspects of regulatory document submissions through the life of a trial. In addition, this position will define and implement best practice for regulatory management across the Cancer Consortium institutions: Fred Hutchinson Cancer Research Center, Seattle Children’s, the University of Washington and the Seattle Cancer Care Alliance. The position will report directly to the Assistant Director, Clinical Research Regulatory and Compliance.

• Set vision and strategy for growing a regulatory team that manages: multi-site investigator initiated IND trials, industry trials, NCTN studies, and single-site investigator initiated trials.
• Define regulatory team and Consortium best practices for regulatory management; create and maintain Standard Operating Procedures (SOPs) and ensures program compliance with the SOPs.
• Collaborate with Consortium faculty and research teams to provide integrated regulatory support.
• Manage day-to-day regulatory operations and workload of regulatory team, plan resource needs and strategize growth.
• Assists with the development of standard training requirements and assists with ongoing regulatory-related education and training for investigators and Consortium research personnel.
• Represent CRS Quality and Compliance as a regulatory consultant at process improvement workgroups, institutional meetings, and conferences.
• Identify Consortium and program improvement opportunities and lead improvement efforts within team, including technology solutions; identify opportunities for expanding solutions to Consortium study teams.
• Implement commercial electronic regulatory binder software with team, and plan and implement system across Consortium research teams.
• Coordinates with Regulatory Affairs team as needed to address regulatory-related quality and compliance matters.
• Perform internal audits and quality assurance reviews on regulatory files, as needed.
• Liaise with investigators, study teams, sponsors, and Institutional Review Office (IRO) representatives on all clinical trial regulatory operations.

Required Qualifications
• Bachelor’s degree (Master’s degree preferred).
• Minimum of 5 years of regulatory experience in the conduct of interventional, treatment, and/or FDA-regulated clinical trials, preferably oncology trials.
• Experience as a lead or senior research or regulatory coordinator with supervisory experience. Project management experience a plus.