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 department financial processes, including billing compliance and to ensure 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.Qualifications:Minimum EducationBachelor's Degree Healthcare, scientific, or related field (Required) AndBSN Preferred BSN, RN, LPN or MD (Preferred)Minimum Work Experience5 years experience in research administration, coverage analysis and working in a clinical research management system. (Required)Required Skills/KnowledgeExpert 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.Functional AccountabilitiesResponsibilitiesDevelops Coverage Analysis (CA) on CMS policy and National and Local Coverage Determinations. Review clinical research protocols, informed consent forms, sponsor agreements and and determines which procedures are routine, and therefore, billable to Medicare and other third party payers.Code each procedure per the applicable CPT coding guidelines. Identify appropriate research modifiers to be places on claimsDocuments CA determinations to to support the decision-making process. This documentation may be subject to inspection by CMS and regulatory agencies.Determines whether a study is a qualifying clinical trial under CMS Clinical Trial Policy.Builds calendars and coverage analysis in OnCoreParticipates in the development of clinical research budgets as needed, assisting to provide justification for costs, etc. working collaboratively with Business Office staff.Review to the protocol for language that will impact the coverage analysis revise appropriately.Maintain a current knowledge of laws and regulations governing professional fee billing, Medicare' Clinical Trial Policy and newly issued guidance. Develops and provides training on these topics for 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.Performs regular research billing reviews to identify billing compliance and develop and implement corrective actions.Other duties as required.Anticipate and responds to customer needs; follows up until needs are metTeamwork/CommunicationDemonstrate collaborative and respectful behaviorPartner with all team members to achieve goalsReceptive to others' ideas and opinionsPerformance Improvement/Problem-solvingContribute to a positive work environmentDemonstrate flexibility and willingness to changeIdentify opportunities to improve clinical and administrative processesMake appropriate decisions, using sound judgmentCost Management/Financial ResponsibilityUse resources efficientlySearch for less costly ways of doing thingsSafetySpeak up when team members appear to exhibit unsafe behavior or performanceContinuously validate and verify information needed for decision making or documentationStop in the face of uncertainty and takes time to resolve the situationDemonstrate accurate, clear and timely verbal and written communicationActively promote safety for patients, families, visitors and co-workersAttend carefully to important details - practicing Stop, Think, Act and Review in order to self-check behavior and performance

Created: 2026-04-15