The University of Chicago's Office of Clinical Research (OCR) is seeking a Senior Clinical Research Coverage Analyst to ensure billing compliance for clinical research and support the utilization of the Clinical Trial Management System (CTMS). This role is crucial for evaluating study documents, determining billable services, and ensuring adherence to Medicare Clinical Trial Policy, thereby optimizing clinical trial initiation and financial workflows.
Requirements
- Proficient in computer software systems such as Clinical Trial Management Systems.
- Proficient in medical technology.
- Proficient with the interpretation of Medicare’s Clinical Trial Policy (NCD 310.1), CMS (Centers for Medicare and Medicaid Services) Billing Guidelines, and NCCN (National Comprehensive Cancer Network Guidelines) guidelines.
- Knowledge of relevant FDA regulations affecting coverage decisions.
- Interpret research protocols, budgets, and consent forms to extrapolate billing/coverage information.
- Problem-solve, leveraging information and expertise available.
Responsibilities
- Reviews clinical trial protocols, budgets, contracts, and informed consent documents to determine billing compliance.
- Creates detailed coverage analyses that outline the billing of clinical items and services required by research studies.
- Develops study calendars within the Clinical Trial Management System.
- Ensures consistency in the application of Medicare, applicable rules across studies, and alignment of study documents with billing regulations.
- Communicates the results of coverage analysis to principal investigators and/or study teams, providing detailed explanations and addressing any questions or concerns.
- Triages and manages ticket requests within the intake system, ensuring timely and efficient resolution of CTMS support requests.
- Ensures that coverage analyses outputs are reviewable and auditable for quality and compliance.
Other
- Minimum requirements include a college or university degree in related field.
- Minimum requirements include knowledge and skills developed through 5-7 years of work experience in a related job discipline.
- Clinical research experience such as clinical research conduct, regulatory compliance, or related research activities.
- Coverage analysis experience.
- Strong organizational skills.
- Manage projects at various stages of completion.
- Manage high volume of workload and meet deadlines.
- Demonstrated attention to detail.
