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o To support clinical development by assisting with project oversight, conduct and protocol development of single and multi-center clinical studies. o Responsible for the implementation and direction of clinical projects at the investigational sites. o Supervises and directs the design, preparation, writing and review of clinical documents including protocols, investigators brochures, case reports forms, informed consents and other specialized forms for clinical trials. o Supervises and directs the design, implementation and monitoring of clinical trials. o Makes decisions on recruitment/selection of new investigators, contract research organizational and outside vendors. o Supports clinical development by ensuring the conduct of quality clinical investigations and that Good Clinical Practices (GCP) are followed. o Attends site visits at various intervals to oversee vendor performance and site operations, and coordinates clinical activities at investigational sites to ensure compliance with protocol and overall clinical objectives. o Directs investigator performance and adherence to protocol, and proactively addresses conduct issues and enrollment problems, as necessary. o Prepare clinical reports as needed for regulatory submissions and when requested for presentations and publications. o Oversees the conduct of clinical studies to ensure the quality and integrity of the data. o Follow and participate in the ongoing development of departmental clinical standard operating procedures and clinical guidelines. o Participate in the planning and organization of investigator meetings, ad hoc clinical advisory meetings and other meetings as required. o Propose and negotiate budgets for clinical investigations. o Oversee the design and distribution of study newsletters and other study related mass communications as needed. o Maintain a high level of professionalism through familiarity with clinical literature and participation in project meetings. o Work independently bringing periodic reports and issues to management. o Train and mentor junior staff in the Clinical Affairs Department. o Contributes to team effort by accomplishing related tasks as needed. Qualifications