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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:
Knowledge of Food and Drug Administration, International Conference on Harmonization (ICH), Code of Federal Regulations (CFR), and Good Clinical Practice (GCP) policies and guidelines as they relate to conduction of human clinical trials.
Knowledge of regulatory and administrative requirements of clinical research and translational research projects.
Understanding of theoretical objectives of clinical research projects.
Strong organization, communication, and interpersonal skills to work effectively with study sponsors, investigators, and research personnel involved in research projects.
Understanding of theoretical objectives of clinical research projects.
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.
Ensure research trials and projects meet regulatory requirements and are compliant with federal and institutional policies. This is critical for ensuring the quality of the research, the reputation of the institution, and patient safety. This position may work with minimal supervision and must use sound judgment to assess prioritization of all regulatory affairs to ensure timely submissions to regulatory bodies (IRB, FDA, sponsor, etc.).
Oversee, coordinate, and implement regulatory submissions to internal and external governing bodies. These include but are not limited to the Institutional Review Board, the Institutional Biosafety Committee, the Institutional Radiation Safety Committee, and the Scientific Review Committee. This includes new study applications, annual reviews, and modifications to existing studies, serious adverse events, and protocol deviations.
Maintains and updates required regulatory documents (FDA Form 1572 and/or 1571, protocol signature page, Investigator’s Brochure, financial disclosures, laboratory accreditations, laboratory reference ranges, CVs, medical licensures, delegation of authority logs, safety reports, trainings, and related forms per sponsor or federal requirements). Identify and maintain training requirements of the research team and collaborators. Maintain, and if needed, implement, standardization and organization of research records and communication in electronic and hard copy format to ensure optimal research compliance and communication within and outside of the research team.
Assist in study start up activities.
Assist in writing Investigational New Drug Applications and annual reports for investigator-initiated clinical trials. Coordinate initial, ongoing submissions and annual reports to the FDA.
Write clinical research trial consent forms in accordance with GCP and FDA guidelines, ensuring all appropriate elements of informed consent. Translate complicated research protocol requirements into language easily understandable by research participants and laypersons.
Assist in the development of protocols for therapeutic clinical trials as well as minimal risk translational research projects and chart review projects.
Assist with processing protocol amendments, translations, continuing reviews, WIRB reportable deviations, Sponsor deviations, etc.
Perform related tasks as assigned.
Prepare interim reports for principal investigators, industry sponsors and Institutional Review Boards to ensure that each project is moving toward timely completion.
As a UW employee, you will enjoy generous benefits and work/life programs. For detailed information on Benefits for this position, click here.
Bachelor's Degree in life sciences plus a minimum of one year related experience.
Strong computer skills and competency with Microsoft Office software.
Strong attention to detail and ability to multi task, organize and prioritize multiple projects.
Excellent written and verbal communication skills.
Demonstrated ability to work independently, under supervision, and be a team player.
Should be highly motivated and flexible, with the ability to adjust to rapidly changing priorities and new projects.
Maintain positive vision, sense of humor, and professional demeanor under potentially stressful situations.
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.
Previous experience conducting research in a hospital or academic setting. Previous regulatory affairs or research coordination experience.
CONDITIONS OF EMPLOYMENT
This position requires a flexible work schedule. Stringent deadlines from pharmaceutical companies for protocol implementation and data collection may require overtime.
Occasional evening and weekend travel to study meetings is required.
The position is located in a clinical and research environment that is located at the Seattle Cancer Care Alliance on the Fred Hutchison Cancer Research Center. Traveling to/from campus buildings is required. Position requires the ability to lift study binders and materials as needed as they may be stored away from immediate desk.
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.
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