The Seattle Cancer Care Alliance (SCCA), located in Seattle, Washington, is part of a dynamic collaboration among three organizations known nationally and internationally for their patient care and research: Fred Hutchinson Cancer Research Center, University of Washington, and Seattle Children's. Over the past 25 years, these institutions have worked together to support their mission of adult and pediatric oncology patient care services, research and education.
The Research Regulatory Coordinator is responsible for overseeing the day-to-day regulatory management of clinical research trials, which include phases I-IV industry, investigator-initiated, and NIH sponsored research studies, and other research projects offered through Research Integration (RI). The role is responsible for ensuring that all such clinical research activity meets regulatory requirements and is compliant with all federal, state, local and institutional policies. The position will manage study start-up, modification submissions, annual/continuous reporting, and study closeout submissions to the Institutional Review Board (IRB) and any other relevant regulatory agencies, committees, the sponsor, funding foundation or governmental agency. Preparation, submission, and maintenance of the regulatory data will require compliance with complex regulations, policies, and procedures regarding the conduct of clinical trials. This is critical for ensuring patient safety, quality of the research and the reputation of the institution. The Research Regulatory Coordinator serves as a liaison to administrative and clinical staff and must serve as a role model as they promote the mission, values, and philosophy of the Seattle Cancer Care Alliance as they perform their duties.
This position reports to the Regulatory Affairs Manager of Research Integration and must maintain effective working relationships with investigators, management and research staff (both internal and external to the organization).