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RESEARCH COORDINATOR
University of Washington
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RESEARCH 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 Medical Oncology has an outstanding opportunity for a full-time Regulatory Coordinator. This position will provide regulatory support to the Thoracic, Head & Neck Oncology Clinical Trials Research Program. At any given time there could be approximately 50 active clinical research trials and anywhere from 10 to 17 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. This position will have knowledge of, and represent, the Thoracic, Head & Neck Oncology Clinical Trials Research Program in all regulatory affairs 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 coordination of industry, investigator-led, and NIH sponsored research studies. This position will also provide team and program support and work at high capacity and quality level. This position will assist with organized improvement efforts, using critical thinking and interpersonal skills to resolve bottlenecks in trial implementation. 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 departments, federal agencies, and industry partners. This position reports to the Thoracic, Head & Neck Oncology Clinical Trials Research Program Manager. This position is required to constantly integrate information from multiple sources to ensure that all research proposals meet the requirements of the University, the Food and Drug Administration, the National Institutes of Health, and the study sponsor. This position requires independent decision making in all aspects of the research study start up process as well as ongoing regulatory study maintenance. This position is also responsible for supporting sponsor-initiated, FDA-initiated, and institution-initiated audits of study data. The position will interact with representatives from pharmaceutical companies and health care providers in a manner that well-represents the University of Washington and its associated institutions (FHCRC and SCCA). This position is required to coordinate efforts across the Alliance partners including UWMC, FHCRC, and SCCA departments and staff. This position contributes to the ongoing success of the Thoracic, Head & Neck Oncology Clinical Trials Research Program and will be instrumental in providing oversight of research regulatory compliance. This position will not only impact this research program but also the Division of Medical Oncology to ensure compliance with all regulatory requirements. This position requires a strong partnership with faculty and staff within and external to the program. Knowledge, Skills and Abilities: (CFR), and Good Clinical Practice (GCP) policies and guidelines as they relate to conduction of human clinical trials. 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 contributions to research development and implementation for the Division of Oncology. It is responsible for overseeing the management of clinical trials, the majority of which provide significant financial support for the Division of Oncology. Furthermore, at any one time up to 100 oncology patients from various Phase I, II and III oncology trials will be enrolled on these clinical trials. This position must be able to work independently on multiple research projects with minimal written policies or procedures. This position requires daily interaction with pharmaceutical sponsors, physicians, other health care personnel (e.g. nurses, patient care coordinators, insurance companies), and patients. Up to 20 projects will be in progress simultaneously, with the expectation of additional projects in the future. Regulatory Affairs Other Projects 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: 183364
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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