This position reports directly to the Director of Clinical Affairs to facilitate the completion of pre-clinical and clinical research projects. The successful candidate will be responsible for coordination, implementation, and monitoring of clinical trials, and working with an interdisciplinary team to coordinate activities required to initiate, monitor and complete clinical programs both domestically and internationally.

Primary responsibilities will include:

• Assists in the management of clinical studies, including monitoring day-to-day activities of trial sites, performing site visits, conducting site training, conducts initiation, interim, close out and audit visits.
• Creates and collaborates on study protocols, study reports, regulatory reports for preclinical studies and support for regulatory submissions.
• Assists in development and review of clinical protocols, case report forms (CRFs) and monitoring plans for pre and post-market studies.
• Communicates with internal departments as needed.
• Works with interdisciplinary teams for the coordination of activities related to clinical programs.
• Supports the development of departmental SOPs, personnel and training programs;
• Reviews study data and resolution of queries;
• Assists production of and reviews clinical study reports;
• Other duties as assigned.

• BS (MS preferred) in a life science or medial discipline (nursing, pharmacy, etc.)
• Five years of experience (three years with MS) in a clinical research or clinical trials setting (medical device preferred).
• A strong working knowledge of medical/scientific terminology and knowledge of FDA regulations and ICH guidelines is required.
• Ability to manage multiple projects simultaneously.
• Excellent written and verbal communication skills.
• Ability to travel (domestic and internationally)

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