Sr. Clinical Research Coverage Analyst

The Sr. Clinical Research Coverage Analyst is responsible for reviewing clinical research protocols, Informed Consent Forms, and other relevant study-related documents. The Coverage Analyst determines whether proposed clinical research studies are a qualifying clinical trial as defined by the Medicare Clinical Trial Policy (NCD 310.1), while also being cognizant of Medicare/Medicaid Benefit Policies, third‑party Medical Benefit Policies, relevant National Coverage Determinations (NCDs) and Local Coverage Determinations (LCDs), Code of Federal Regulations (CFRs), state laws, professional practice guidelines, claims denial reports from the Institution and, when necessary, consult with the Medicare Administrative Contractor (MAC) for the region.

Provides skilled clinical trial review and analysis for a variety of departmental financial processes, including billing compliance, and ensures proper cost coverage for the Informed Consent. Impacts operational procedures and practices in the department. Performs special assignments as required and prepares detailed audit reports, cost reports, etc., for departmental and institutional use.

• Bachelor’s Degree in Healthcare, Scientific, or Related Field (Required)
• BSN, RN, LPN, or MD (Preferred)

• 8 years of experience in research administration (Required)

• Expert knowledge of Medicare Clinical Trial Policy (NCD 310.1), National and Local Coverage Determinations (NCDs/LCDs), Code of Federal Regulations (CFRs), state laws, and professional practice guidelines.
• Knowledge of regulations regarding human subjects in clinical research, outcomes research, nursing research, and other research areas.
• Proficient working knowledge of Microsoft Office Suite, including Excel and multiple IT systems.
• Experience with OnCore Clinical Trials Management System (CTMS) is required.
• Effective verbal, written, and interpersonal communication skills.
• Ability to organize/prioritize time and work independently.
• Ability to apply generalized information to specific situations.
• Knowledge of drug/device development process and the pharmaceutical and/or medical device manufacturing industry.

• Develop Coverage Analysis (CA) on CMS policy and National and Local Coverage Determinations. Review clinical research protocols, informed consent forms, sponsor agreements and determine which procedures are routine and therefore billable to Medicare and other third‑party payers.
• Code each procedure per the applicable CPT coding guidelines and identify appropriate research modifiers to be placed on claims.
• Document CA determinations to support the decision‑making process. This documentation may be subject to inspection by CMS and regulatory agencies.
• Determine whether a study is a qualifying clinical trial under CMS Clinical Trial Policy.
• Build calendars and coverage analysis in OnCore.
• Participate in the development of clinical research budgets as needed, assisting to provide justification for costs and working collaboratively with Business Office staff.
• Review the protocol for language that will impact the coverage analysis and revise appropriately.
• Maintain current knowledge of laws and regulations governing professional fee billing, Medicare Clinical Trial Policy and newly issued guidance. Develop and provide training on these topics for investigators and CNH research and administrative staff.
• Assist with the development of policies and procedures pertaining to clinical research billing compliance, including the CA process.
• Perform regular research billing reviews to identify billing compliance and develop and implement corrective actions.
• Other duties as required.
• Anticipate and respond to customer needs; follow up until needs are met.

• Demonstrate collaborative and respectful behavior.
• Partner with all team members to achieve goals.
• Receptive to others’ ideas and opinions.

• Contribute to a positive work environment.
• Demonstrate flexibility and willingness to change.
• Identify opportunities to improve clinical and administrative processes.
• Make appropriate decisions using sound judgment.

• Use resources efficiently.
• Search for less costly ways of doing things.

• Speak up when team members appear to exhibit unsafe behavior or performance.
• Continuously validate and verify information needed for decision making or documentation.
• Stop in the face of uncertainty and take the time to resolve the situation.
• Demonstrate accurate, clear, and timely verbal and written communication.
• Actively promote safety for patients, families, visitors, and co‑workers.
• Attend carefully to important details—practice Stop, Think, Act and Review to self‑check behavior and performance.