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IND Protocol Development Specialist
We are seeking an IND/Protocol Development Specialist who will serve as a central resource for faculty conducting investigator-initiated clinical trials at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The candidate will be responsible for reviewing investigator-initiate protocols, filing for Investigational New Drug (IND) and Investigational Device Exemption (IDE) applications to the FDA, long-term IND/IDE management, Institutional Review Board (IRB) approval, and ensuring that all trials conform to Good Clinical Practice (GCP) standards. The IND/Protocol Development Specialist, as part of the centralized Clinical Research Office (CRO), will provide hands-on support for investigators in protocol development, collaborate with the study team through reg
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