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Regulatory Compliance Specialist-2
Location: Hyde Park CampusJob Description:Preparation and collection of all necessary documents to activate protocols (e.g. consent forms, Form FDA 1572, etc.).Preparation and submission to the IRB and other applicable internal review committees including submission of new study applications, amendments, and continuing reviews.Creation and maintenance of site regulatory files for each assigned study.Communication of updates and changes (e.g. protocol amendments) to the clinical research team and sponsor/funding agencies.Participation in internal clinical research audit program (as assigned).Multi-site Regulatory Coordination (as assigned):Act as the primary regulatory liaison for external sites participating in clinical res


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