Study Start Up Specialist Sr

SS: Clinical Trial Center- (Full-Time, Day Shift) -

Job Summary: The Study Start Up Specialist Senior 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). Mentors and trains the new start up staff that enter the department. 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 five 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: Detailed understanding of Medicare's Clinical Trial Policy (NCD 310.1) and related guidance documents. 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 keyboard 40 wpm. 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. Communicates effectively and serves as a subject matter expert on coverage analysis.

Licensures and Certifications: None.