Clinical Research Associate (CRA)/Sr. Clinical Research Associate (CRA)

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Under general supervision: accountabel for the timely initiation, conduct and completion of pre- and post-market clinical studies according to appropriate regulatory and departmental guidelines.  Principal duties:  Perform all job duties in full accordance with the Worldwide Policies on Information Asset Protection, maintain password(s) as Confidential, and protect Critical Business Information. Incumbent knows, understands, incorporates and complies with all applicable laws and regulations relating to DePuy’s business activities and Policies and Procedures of the Health Care Compliance Program and Code of Conduct.Develops and manages clinical studies in support of marketed products. Develops and manages clinical studies to support marketing approval of products by a regulatory agency (IDE studies). Coordinates with internal regulatory group on inclusion of clinical protocols, data and summary reports in regulatory submissions. Prepare internal reports and FDA submissions on the conduct and results of clinical investigations Maintain clinical investigation regulatory compliance (IRB, IPC, complication reporting, inventory control, data reporting, record keeping, etc.) Interface with surgeons, investigators, IRB’s, FDA, and appropriate company personnel as required regarding clinical investigations Perform site monitoring in accordance with FDA guidelines and regulations and department work instructions; coordinates with regional and /or CRO monitors for site concerns/issues raised from site monitoring. Provide recommendations regarding study problems protocol modifications, etc. Initiate investigator agreements, track surgeon compliance with clinical research agreements and initiate payments.  Maintains timely and accurate documentation and communication of clinical study progress and issues. Organizes and participates in investigator meetings.

Coordinate the prepartation of scientific presentations, publication and submissions.

Occasional attendance at scientific/technical meetings

BS/Nursing, Pharmacy, or Scientific Field. 0-5 years experience in pharmaceutical clinical research; knowledgeable of FDA GCP regulations/medical device regulations (501(k), PMA); Travel as required (estimated 10-30% annual travel).