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REGULATORY COORDINATOR
University of Washington
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REGULATORY COORDINATOR
University of Washington
Details
Salary:
Open
Type:
Full Time
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. All of which has allowed the UW to be nationally recognized as a “Great College to Work For” for six consecutive years. The Division of Hematology has an outstanding opportunity for a full-time Regulatory Coordinator. This position will provide regulatory support to the UW Hematology Research Program. This position will work with 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 pharmaceutical sponsors, funding foundation or governmental agency. In addition, this position will have knowledge of and represent our research programs in all regulatory affair requirements mandated by the three Cancer Consortium partner institutions: the University of Washington (UW), Seattle Cancer Care Alliance (SCCA), and Fred Hutchinson Cancer Research Center (FHCRC), in addition to the governmental regulatory requirements. This position requires knowledge of protocol requirements as set forth by federal regulations, knowledge of the academic clinical trial healthcare regulatory operations to effectively facilitate the work flow and promote a collaborative work environment. The position requires effective communication with the study investigators, research staff, numerous UW, SCCA, and FHCRC departments, federal agencies and industry partners. This position is supervised by and reports to the Clinical Research Manager of the UW Hematology Clinical Research program and works in close alliance with all members of the program. Under administrative direction as our 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 coordination of the regulatory submissions in the study start-up phase to meet sponsor and institutional timelines. This position is required to coordinate efforts across the alliance partners including UW, SCCA, FHCRC and at times Seattle Children’s Hospital. This position will work with the Research 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 must be able to work independently on multiple research projects without the benefit of written policies or procedures. This position requires daily interaction with physicians, research staff at internal and collaborating institutions, pharmaceutical company sponsors, and any other groups integral to the successful completion of research projects. This position is critical to the success of the UW Hematology Clinical 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 Hematology 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: 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 Hematology. The regulatory coordinator is responsible for overseeing the regulatory affairs of the UW Hematology Clinical Research Program's clinical trials and research studies. This individual will be responsible for overseeing the regulatory coordination of ~50 active phase l-lll clinical trials, in addition to the startup of an additional 1-15 clinical trials. Duties and Responsibilities: As a UW employee, you will enjoy generous benefits and work/life programs. For detailed information on Benefits for this position, click here. REQUIREMENTS Additional Requirements: Applicants selected for this position who have not already completed the training for clinical research involving human subjects will be required to complete this training Equivalent education/experience will substitute for all minimum qualifications except when there are legal requirements, such as a license/certification/registration. DESIRED CONDITIONS OF EMPLOYMENT Application Process: The application process for UW positions 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 Workforce 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 access your “My Jobs” page. If you select to take it later, it will appear on your "My Jobs" page to take when you are 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. |
Internal Number: 186185
About University of Washington
Founded in 1861, the University of Washington is one of the oldest public institutions in the west coast and one of the preeminent research universities in the world. The University of Washington is a multi-campus university comprised of three different campuses: Seattle, Tacoma, and Bothell. The Seattle campus is made up of sixteen schools and colleges that serve students ranging from an undergraduate level to a doctoral level. The university is home to world-class libraries, arts, music, drama, and sports, as well as the highest quality medical care in Washington State and a world-class academic medical center. The teaching and research of the University’s many professional schools provide undergraduate and graduate students the education necessary toward achieving an excellence that will serve the state, the region, and the nation. As part of a large and diverse community, the University of Washington serves more students than any other institution in the Northwest.
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