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 Operations Manager will be responsible for overseeing the day-to-day regulatory management of intervention oncology clinical trials, including: investigator-initiated trials, NCI National Clinical Trial Network (NCTN) trials (cooperative group clinical trials) and industry-sponsored trials., as well as Institution-Sponsored, Investigator-Initiated Trials. The position will manage all aspects of study start-up, modification submissions, continuous reporting, and study close-out to the Institutional Review Board (IRB) and any relevant regulatory agencies including, the Institutional Biosafety Committee, the institutional Radiation Safety Committee, and the pharmaceutical sponsor, funding foundation, or governmental agency. In addition, this position will have knowledge of and represent these research programs in regulatory affairs requirements mandated by Cancer Consortium partner institutions: Fred Hutchinson Cancer Research Center, the University of Washington and the Seattle Cancer Care Alliance. The Regulatory Operations Manager is responsible for managing other regulatory coordinators and regulatory assistants. The position will report directly to the Clinical Research Support (CRS) Quality and Compliance Manager.
Manage day-to-day regulatory operations and workload of regulatory team, plan resource needs and strategize growth.
Represent CRS Quality and Compliance as a regulatory consultant at process improvement workgroups, institutional meetings, and conferences
Provide regulatory support to NCI NCTN program and Institution-Sponsored IND (ISI) Program and oversee maintence of all required regulatory documents.
Provide regulatory start-up support for the central Study Start-up Team including industry-sponsored and investigator-initiated trials.
Partner with Consortium study teams to provide ad hoc regulatory management for ongoing clinical trials.
Oversee, coordinate, and prepare regulatory study start-up documents and maintenance of protocol submissions to internal and external governing bodies. These include but are not limited to the Cancer Consortium IRB, NCI Central IRB, the Institutional Biosafety Committee, Radiation Safety Committee, and Scientific Review Committee.
Oversees timely regulatory submissions to meet institutional, NCI NCTN and other relevant project timelines.
Create and maintain Standard Operating Procedures (SOPs) and ensures program compliance with the SOPs.
Identify program improvement opportunities and lead improvement efforts within team, including technology solutions; identify opportunities for expanding solutions to Consortium study teams.
Coordinates with Regulatory Affairs team as needed to address regulatory-related quality and compliance matters.
Assists with the development of standard training requirements and assists with ongoing regulatory-related education and training for. investigators and research personnel Perform internal audits and quality assurance reviews on regulatory files, as needed
Write and edit clinical research trial consent forms in accordance with FDA regulations and guidances and GCP guidelines.
Liaise with investigators, study teams, sponsors, and Institutional Review Office (IRO) representatives on all clinical trial regulatory operations.
Fred Hutchinson Cancer Research Center, home of three Nobel laureates, is an independent, nonprofit research institution dedicated to the development and advancement of biomedical research to eliminate cancer and other potentially fatal diseases. Recognized internationally for its pioneering work in bone-marrow transplantation, the Center’s five scientific divisions collaborate to form a unique en...vironment for conducting basic and applied science. The Hutchinson Center, in collaboration with its clinical and research partners, the University of Washington and Seattle Children’s, is the only National Cancer Institute-designated comprehensive cancer center in the Pacific Northwest. Join us and make a difference!