Study Start Up Specialist
About The Position
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.
Requirements
- Bachelor's Degree in a health-related discipline required.
- Minimum two years of experience in clinical research required.
- 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.
- Able to collaborate and accept direction.
- Able to think critically.
- Able to manage multiple assignments effectively.
- Able to organize and prioritize workload.
- Able to work well under pressure.
- Able to problem solve.
- Able to recall information with accuracy.
- Able to pay close attention to detail.
- Able to work independently with minimal supervision.
- Able to distinguish colors as necessary.
- Able to hear sufficiently for general conversation in person and on the telephone, and identify and distinguish various sounds associated with the workplace.
- Able to see adequately to read computer screens, and written documents necessary to the position.
Nice To Haves
- One year of experience with HCPCS/CPT coding preferred.
- Experience may be accepted in lieu of degree.
Responsibilities
- Reviewing clinical research studies to determine if they qualify under Medicare's National Coverage Determination (310.10).
- Coordinating the startup process for clinical research studies.
- Reviewing study protocols and related regulatory documents.
- Assisting with feasibility determination.
- Assisting with billing plan creation.
- Completing coverage analyses.
- Completing study startup kits.
- Establishing research records in the electronic medical record system.
- Performing other duties as needed.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
