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REGULATORY AFFAIRS COORDINATOR
University of Washington
2021-12-03 12:45:11
Seattle,
Washington,
United States
Job type: fulltime
Job industry: Government & Defence
Job description
As a UW employee, you have a unique opportunity to change lives on our campuses, in our state and around the world. UW employees offer their boundless energy, creative problem solving skills and dedication to build stronger minds and a healthier world.
UW faculty and staff also enjoy outstanding benefits, professional growth opportunities and unique resources in an environment noted for diversity, intellectual excitement, artistic pursuits and natural beauty.
The University of Washington's Division of Medical Oncology includes 41 faculty members located at the UW Medical Center, the Fred Hutchinson Cancer Research Center, the Seattle Cancer Care Alliance, and the VA Puget Sound Health Care System. Over the past 25 years, members of the Division have developed the world's leading bone marrow transplant program. In addition, members of the Division have made substantial contributions to many other areas of cancer treatment, including the use of tumor vaccines, cellular therapy for cancer, antibody-based treatments, and novel forms of chemotherapy and hormonal therapy. Our Division is deeply committed to maintaining its position as one of the leading centers for research and treatment of cancer in the world.
The Division of Medical Oncology has an outstanding opportunity for a full-time Regulatory Affairs Coordinator. This position will provide regulatory support for the Sarcoma Research Program. At any given time, there will be approximately 40 active clinical research trials and anywhere from 5-10 trials in the process of being activated. This position will oversee all aspects of submission and continuous reporting to the relevant regulatory agencies, including the Institutional Review Board, the Food and Drug Administration, 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 all regulatory affair requirements mandated by the three Cancer Consortium partner institutions: the Seattle Cancer Care Alliance, Fred Hutchinson Cancer Research Center, and the University of Washington, in addition to the governmental regulatory requirements. This position will oversee the regulatory management of phases I-IV industry, investigator-led, and NIH sponsored research studies.
The purpose of this position is to manage and administer the regulatory affairs of the Sarcoma Program. This position will work closely with the Sarcoma Program leadership, preparing documents for IRB submission of clinical research protocols. This position will coordinate the collection and submission of regulatory and research protocol required documents to Sponsors, Seattle Cancer Care Alliance, Fred Hutchinson Cancer Research Center and the University of Washington. Ongoing regulatory management of various phases of industry, investigator and NIH initiated clinical trials will be part of this position.
The Division of Oncology is physically located in the Seattle Cancer Care Alliance on the Fred Hutchinson Cancer Research Center campus. This position requires operational knowledge of the University of Washington, Fred Hutchinson Cancer Research Center, and Seattle Cancer Care Alliance. This position is required to use independent judgment, leadership and knowledge of the academic clinical trial healthcare regulatory operations to effectively facilitate the work flow and promote a collaborative work environment. The position will maintain dynamic communication with the study investigators, research staff, numerous University departments, SCCA departments, and the FHCRC departments, federal agencies and industry partners.
This position will work with minimal supervision in performing work assignments and will work closely with program management, the Research Coordinators, and Data Manager in making judgments and decisions within guidelines of UW and sponsor agency policies.
This position is constantly required to integrate information from multiple sources to ensure that all research protocols are correctly navigated through the institutional start up procedures, and submitted within the IRB, Cancer Consortium and Sponsor required guidelines.
This position requires independent decision making on all aspects of the research study start up process as well as ongoing regulatory affairs work. This position is required to coordinate efforts across the Alliance partners including UWMC, FHCRC, SCCA, and Harborview departments and staff.
This position is key to the success of the Sarcoma Program. It will require a strong partnership with faculty and staff within and external to the program.
Knowledge, Skills and Abilities:
The mission statement of the University of Washington Medical Center states that the Medical Center serves as a research resource, providing an environment in which clinical research may be conducted. This position is essential to that mission. This position provides significant contributions to research development, implementation and regulatory compliance for the Division of Oncology. It is responsible for overseeing the regulatory affairs of the Sarcoma Oncology clinical trials, the majority of which provide significant financial support for the Division of Oncology.
This position is supervised by and reports to the Regulatory Affairs Manager of the Sarcoma Research Program.
This position will work independently under administrative direction and will be the expert resource for faculty and research staff on clinical research regulatory policies, procedures, and processes. The successful candidate will need to understand the research protocols and translate research needs into appropriate regulatory requirements. This will require integration of information from multiple sources and use of specialized regulatory knowledge of the governing clinical research policies, to ensure all clinical trials are compliant with applicable federal and institutional regulations.
This position will be responsible for expeditious coordination of the regulatory submissions in the study start-up phase to meet sponsor and institutional timelines, which is a key metric by which sponsors assess the site. This position is required to coordinate efforts across the Alliance partners including UWMC, FHCRC, and SCCA departments and staff.
This position will work to create and maintain program Standard Operating Procedures (SOPs), as well as ensure program compliance with the SOPs. This position may also perform Quality Assurance checks on regulatory files as needed.
This position is critical to the success of the Sarcoma Research Program and will be instrumental in providing oversight of all research regulatory compliance. This position will not only impact these research programs but also the Division of Medical Oncology ensuring compliance with all regulatory requirements. It will require a strong partnership with faculty and staff within and external to the program.
Regulatory Affairs