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Regulatory Coordinator - Clinical Trial Office
The Vaccine Regulatory Coordinator (Vaccine RC) works directly for the Clinical Trials Office to complete regulatory requirements specific to vaccine research. This position serves as the primary reporting contact for the high-risk vaccine IND portfolio managed by the CTO Regulatory Affairs Core. The Vaccine RC centrally prepares, submits and maintains records on assigned vaccine INDs to ensure regulatory compliance with all Food and Drug Administration (FDA), National Institutes of Health Office of Special Projects (NIH OSP), and institutional biosafety committee (IBC) requirements. This position works collaboratively with various departments within DFCI and the other DF/HCC institutions, as well as with representative from federal agencies. As necessary, the vaccine RC assists th
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