Study Start Up Specialist

Job Summary : The Study Start Up Specialist is responsible for reviewing clinical research studies to determine whether the study is a qualifying study pursuant to Medicare's National Coverage Determination (310.10). Coordinates the startup process of clinical research studies submitted to the Clinical Trial Center by reviewing study protocols and related regulatory documents in order to assist with feasibility determination, billing plan creation, complete coverage analyses and study startup kit completion. Is responsible for establishing research records in electronic medical record system. Performs other duties as needed.

Education and Experience : Bachelor's Degree in a health-related discipline required. Minimum two years of experience in clinical research required. One year of experience with HCPCS / CPT coding preferred. Experience may be accepted in lieu of degree.

Knowledge and Skills : Understanding of FDA and Medicare regulations related to clinical trials. Ability to interpret research contracts, study budgets and clinical protocols and consent forms to extrapolate billing / coverage data. Able to use a computer, printer, and software programs necessary to the position (e.g., Word, Excel, Outlook, PowerPoint). Operate / troubleshoot basic office equipment required for the position. Able to work calmly and respond courteously when under pressure; collaborate and accept direction. Able to think critically; manage multiple assignments effectively; organize and prioritize workload; work well under pressure; problem solve; recall information with accuracy; pay close attention to detail; work independently with minimal supervision. Able to distinguish colors as necessary; hear sufficiently for general conversation in person and on the telephone, and identify and distinguish various sounds associated with the workplace; see adequately to read computer screens, and written documents necessary to the position.

Licensures and Certifications : None.

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