We are seeking a Clinical Research Program Specialist who will serve as a central resource for faculty conducting clinical research at Johns Hopkins University and across multiple clinical trial sites. Under the supervision of the Lead Regulatory Manager, the Clinical Research Program Specialist is responsible for the regulatory filings for Investigational New Drug (IND) applications to the FDA, long-term IND management, Institutional Review Board (IRB) approval, and ensuring that all trials conform to Good Clinical Practice (GCP) standards. Long-term IND management includes submission of protocol, Investigator Brochure, and Chemistry Manufacturing and Controls (CMC) amendments, IND annu
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