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U W-MADISON DIV. CONTINUING STUDIES Regulatory Coordinator in MADISON, Wisconsin

JOB REQUIREMENTS: Job Summary: The Regulatory Coordinator provides comprehensive investigator support services for clinical research in the Department of Family Medicine and Community Health at the UW School of Medicine and Public Health (SMPH). To carry out these activities, the incumbent will work closely with both the Health Sciences Institutional Review Board (HS-IRB) and the Health Sciences Minimal Risk Institutional Review Board (MR-IRB). This position reports to the Director of Research Operations. This position is responsible for distilling complex scientific protocols into clear, concise, and accurate clinical research applications, consent forms, and correspondence. Most critical is the ability to manage many detailed projects simultaneously, completing projects in a timely manner, and meeting strict deadlines required by review committees, boards, as well as, by investigators and sponsors of clinical research. Responsibilities: Provides regulatory support for research studies. Assists in all regulatory activities including reviewing documents, applications, and reports, and ensuring compliance with the internal and external regulatory framework. Ensures compliance with all regulations, laws, and research standards pertaining to research. Applies skills to a broad range of different types of studies, navigates resources, and identifies issues needing escalation. Performs quality checks and may train staff. Contributes to the development of new team and unit processes, procedures, tools, and training. 15% Develops, prepares, and submits protocol-specific application materials to regulatory bodies such as the Institutional Review Board and scientific review committee 15% Develops clear and accurate informed consent documents 20% Serves as regulatory contact person for research studies involving human subjects 15% Maintains complete and accurate regulatory files and records 5% Communicates directly with protocol sponsors related to regulatory documents and activities 15% Provides guidance and direction to research teams regarding compliance with policies, procedures, and regulations 5% Performs quality checks 5% May lead and train other staff 5% Contributes to... For full info follow application link. The University of Wisconsin-Madison is an Equal Opportunity and Affirmative Action Employer. Qualified applicants will receive consideration for employment without regard to, including but not limited to, race, color, religion, sex, sexual orientation, gender identity, national origin, age, pregnancy, disability, or status as a protected veteran and other bases as defined by federal regulations and UW System policies. We promote excellence through diversity and encourage all qualified individuals to apply. If you need to request an accommodation because of a disability, you can find information about how to make a request at the following website: https://employeedisabilities.wisc.edu/disability-accommodation-information-for-applicants/ ***** APPLICATION INSTRUCTIONS: Apply Online: ipc.us/t/B6EB3B4D77CF469F

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