Clinical Research Coverage Analyst

Department

BSD OCR - CTMS Support Unit

The Office of Clinical Research (OCR) is dedicated to supporting the infrastructure for the management and administration of clinical research at The University of Chicago as well as individual research programs with the goal of improving communication, consistency, and collaboration across the Biological Sciences Division and UChicago Medicine.

To mission of the OCR is to catalyze clinical research by providing expertise, resources, infrastructure, and systems that facilitate clinical research operations and enable collaboration across the enterprise while promoting compliance and human subject protection on behalf of our diverse community of patients and volunteers.

The coverage analyst is dedicated to ensuring billing compliance for clinical research and supports utilization of the Clinical Trial Management System (CTMS), Oncore. The coverage analyst evaluates clinical research protocols, informed consent forms, clinical trial budgets, and other pertinent study documents to generate a protocol calendar in the CTMS system and develop coverage analysis/billing grid. The coverage analyst specifies procedures and services that qualify as 'Routine Cost' and are billable to patient insurance versus charged to the study.

The coverage analyst is responsible for determining whether proposed clinical research studies meet the criteria for a Qualifying Clinical Trial as defined by the Medicare Clinical Trial Policy (NCD 310.1). As a member of the Research Systems & Coverage Analysis (RSCA) Unit within the Office of Clinical Research, the coverage analyst works as part of a team to support and optimize clinical trial initiation and financial workflows, partnering closely with research teams and key stakeholders in the process.

• Reviews clinical trial protocols, budgets, contracts, and informed consent documents to inform billing designations.
• 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, Oncore.
• Ensures consistency in the application of Medicare and other applicable rules across studies and alignment of study documents with billing regulations.
• Works collaboratively with key offices, including the Human Research Protection Program and research units, to harmonize regulatory and budgetary processes in clinical trials.
• Communicates the results of coverage analyses to principal investigators and/or study teams, providing detailed explanations and addressing any questions or concerns.
• Ensures that coverage analyses outputs are reviewable and auditable for quality and compliance.
• Recruits, onboards, and trains new clinical research staff to ensure adherence to billing compliance procedures.
• Coordinates department or clinic compliance with a moderate level of guidance.
• Prepares, completes and submits all compliance documentation on a routine basis. Coordinates compliance committee meetings.
• Performs other related work as needed.

• Education:
  
  Minimum requirements include a college or university degree in a related field.
• Work Experience:
  
  Minimum requirements include knowledge and skills developed through 2-5 years of work experience in a related job discipline.

• Education:
  
  Bachelor's degree.
• Experience:
  
  Clinical research experience such as clinical research conduct, regulatory compliance, or related research activities.
• Experience:
  
  Coverage analysis experience.

• Interpret research protocols, budgets, and consent forms to extrapolate billing/coverage information.
• Problem-solve, leveraging information and expertise available.
• Strong organizational skills.
• Manage projects at various stages of completion.
• Manage high volume of workload and meet deadlines.
• Demonstrated attention to detail.

• Office environment.

• Resume (required)
• Cover Letter (preferred)

Yes. The University of Chicago offers a wide range of benefits programs and resources for eligible employees, including health, retirement, and paid time off. Information about the benefit offerings can be found in the Benefits Guidebook.

The University of Chicago is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender, gender identity, or expression, national or ethnic origin, shared ancestry, age, status as an individual with a disability, military or veteran status, genetic information, or other protected classes under the law. For additional information please see the University's Notice of Nondiscrimination.

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