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The Research Regulatory Specialist Senior is responsible for providing support for implementation of clinical trials. Performs a wide variety of start-up activities integral to the successful application and acceptance of essential regulatory documents for clinical research protocols. Responsible for ensuring submission of documents to pharmaceutical sponsors, Institutional Review Board (IRB), and contract research organizations (CRO) as applicable. Serves as a liaison between the various sponsors, IRB, and internal departments/staff in order to implement clinical trials and research projects with minimal protocol deviations. Assists and guides new and junior team members.

GENERAL DUTIES

Protocol Regulatory Management: