Overall responsibility for the conduct of internal and external audits to ensure compliance with current Good Clinical Practices (cGCP) in accordance with regulatory standards for clinical trials and to ensure integrity of clinical research data and other data to support regulatory filings.

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Assists with all aspects of the design, planning, and implementation of clinical research projects. Participates in and coordinates the protocol and final clinical study report writing efforts. Assists with conduct of pre-study, initiation, and interim clinical study monitoring visits. Coordinates activities of clinical site to ensure compliance with protocol and overall clinical objectives.

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