The Clinical Trial Coverage Analyst is an integral member of the Office of Clinical and Community Trials (OCCT). Under the direction of the Director, Research Operations and Conduct (ROC), the Clinical Trial Coverage Analyst is responsible for the development and review of Medicare Coverage Analysis (MCA) documents for qualifying clinical trials, understanding the budget and negotiation process and ensuring consistency and harmonization across research claims review, internal budget, funder budget, contract, and informed consent documents to uphold Research Institute and Hospital policies and clinical research billing compliance policy and guidance.

Essential Job Functions

• Reviews human subjects research studies to determine if they are qualified clinical trials pursuant to Medicare's National Coverage Determination 310.1.

• Creates billing plan, including Medicare Coverage Analysis (MCA) documentation, in alignment with the Clinical Trial Agreement, budget, and informed consent.

• Determines billable services based on review of the Medicare's Clinical Trial Policy (NCD 310.1), National Coverage Decisions (NCD's), Local Coverage Decisions (LCD's), Code of Federal Regulations (CFRs), state laws and professional practice guidelines.

• Work with Principal Investigators (PI) and research teams to provide accurate guidance for billing policies and procedures.

• Applies the appropriate CPT codes for potentially billable items in the MCA in order to assist in the management of claims review, as well as identifying items that are to be billed to the sponsor.

• Works closely with the Epic research billing team to assist in the creation of clinical trial management system and Epic billing grids.

• Review clinical trial amendments for changes that may impact the MCA. Make required changes as needed.

• Works closely with the Clinical Research Operations Manager, Clinical Trial Budget and Contract Managers, and other key team members to initiate the process for clinical trial determination and MCA review, and to ensure harmonization of the final coverage analysis with the final internal and negotiated budget, Clinical Trial Agreement (CTA) and IRB-approved informed consent form.

• Other job functions as assigned.

Knowledge, Skills and Abilities

• Bachelor's Degree and 4 years of clinical trial experience OR a combination of 8 years of relevant work experience in Medicare coverage analysis creation, clinical research conduct, clinical research regulatory compliance, clinical research billing, and/or clinical research/trial budget and contract management.

• Understanding of study budgets, informed consent forms, and CTA cost language.

• Strong understanding of research billing compliance required. Ability to interpret research protocol information essential.

• Working knowledge of medical terminology.

• Ability to work independently and as a member of a team and follow through on assignments with minimal direction required.

• Demonstrated accuracy and precision, attention to detail, and exceptional organizational skills essential.

• Strong verbal and written communication skills required.

• Ability to manage large quantities of data in a manner which facilitates sharing of information.

• Ability to handle high volume of work with changing priorities and constant interruptions and establish priorities and deadlines required.

• Ability to prepare accurate documentation of events required.

• Ability to maintain confidential material and information required.

• Personal computer skills; functional experience with integrated software systems and proficient in Microsoft Office applications.