REGULATORY COORDINATOR |
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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 Center, 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 Coordinator (Research Coordinator (E S 7)). This position is one of three who will provide regulatory support to the UW Hematologic Malignancies Research Program. At any given time, there will be up to 80 active clinical research trials/research projects and up to 20 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 (FDA), 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 University of Washington (UW) and Fred Hutchinson Cancer Center (FHCC), in addition to the governmental regulatory requirements. Position Complexities: This position will oversee the regulatory management. This position is required to use independent judgment, leadership and expert 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 UW, and FHCC departments, federal agencies and industry partners. This position is supervised by and reports to the Senior Regulatory Affairs Coordinator of the UW Hematologic Malignancies team. This position will work in close alliance with all members of the Program, including the Program's incumbent Regulatory Coordinators. This position will work independently under administrative direction and will be an expert resource for faculty and research staff on clinical research regulatory policies, procedures, and processes. This position will need to understand research protocols and translate research needs into appropriate regulatory requirements. The regulatory coordinator will integrate information from multiple sources and use 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 the sponsor will assess the site. This position is required to coordinate efforts across the alliance partners including UW and FHCC departments and staff. This position will work with the Clinical Research Program Manager to create and maintain applicable Standard Operating Procedures (SOPs)/guidelines, as well as ensure compliance with the SOPs/guidelines. This position may also perform Quality Assurance checks on regulatory files as needed and implement/maintain relevant training of research staff and collaborators. This position will also implement and maintain standardization of research records in both electronic and hard copy format in order to simplify cross coverage and ensure optimal research compliance and communication. This position is critical to the success of the UW Hematologic Malignancies 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. Knowledge, Skills and Abilities: Position Dimensions and Impact to the University: 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 Medical Oncology. The regulatory coordinator is responsible for overseeing the regulatory affairs of the UW Hematologic Malignancies Research Program's clinical trials and research studies. This individual will be responsible for overseeing the regulatory coordination of up to 30 active clinical trials, in addition to the start-up of an additional 1-10 clinical trials. At any one time up to 1000 oncology patients may be enrolled on these clinical trials with additional patients on research studies. DUTIES AND RESPONSIBILITIES Regulatory Affairs- 90% Other tasks as assigned -10% MINIMUM REQUIREMENTS ADDITIONAL REQUIREMENTS DESIRED QUALIFICATIONS CONDITIONS OF EMPLOYMENT Application Process: The application process may include completion of a variety of online assessments to obtain additional information that will be used in the evaluation process. These assessments may include Work Authorization, Cover Letter and/or others. Any assessments that you need to complete will appear on your screen as soon as you select “Apply to this position”. Once you begin an assessment, it must be completed at that time; if you do not complete the assessment, you will be prompted to do so the next time you your “My Jobs” page. If you select to take it later, it will appear on your "My Jobs" page to take when you are access ready. Please note that your application will not be reviewed, and you will not be considered for this position until all required assessments have been completed. |
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Committed to attracting and retaining a diverse staff, the University of Washington will honor your experiences, perspectives and unique identity. Together, our community strives to create and maintain working and learning environments that are inclusive, equitable and welcoming. The University of Washington is an affirmative action and equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, national origin, age, protected veteran or disabled status, or genetic information. To request disability accommodation in the application process, contact the Disability Services Office at 206-543-6450 or dso@uw.edu. Applicants considered for this position will be required to disclose if they are the subject of any substantiated findings or current investigations related to sexual misconduct at their current employment and past employment. Disclosure is required under Washington state law. |
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REGULATORY COORDINATOR