Clinical Research Coverage Analyst

Biological Sciences Division at the University of Chicago; Chicago (IL); On-site; USD 65,000 - 90,000; Full time

Job summary

The Biological Sciences Division at the University of Chicago seeks a Coverage Analyst to maintain regulatory compliance programs and support billing designations for clinical research. You will develop coverage analyses, build CTMS calendars in Oncore, and ensure adherence to Medicare policies across trials, collaborating with key offices to streamline workflows.

You will review protocols, budgets, contracts, and consent forms to determine routine cost allocations and prepare compliant

Qualifications

• Minimum: college/university degree in a related field.
• Preferred: Bachelor's degree.
• Experience in clinical research, regulatory compliance, or related activities; coverage analysis experience.

Responsibilities

• Review protocols, budgets, contracts, and consent documents to inform billing designations.
• Create coverage analyses detailing billing of items and services in each study.
• Develop study calendars within Oncore CTMS.
• Ensure Medicare and other billing regulations are applied consistently across studies.
• Collaborate with HRPP and research units to harmonize regulatory and budgetary processes in trials.
• Communicate coverage analysis results to principal investigators and study teams with explanations.
• Ensure that outputs are reviewable and auditable for quality and compliance.
• Recruit, onboard, and train new clinical research staff on billing compliance procedures.
• Coordinate department compliance with moderate guidance.
• Prepare and submit compliance documentation and coordinate committee meetings.
• Perform other related work as needed.

Skills

Interpret protocols & budgets

Problem solving

Organizational skills

Project management

Attention to detail

Education

Bachelor's degree

Job description

About The Department

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

Job Summary

The role maintains regulatory compliance programs, including interpretation of systems to identify areas of risk and coordination of internal audits. With moderate direction, the analyst participates in compliance documentation, training, and committee formation. The Coverage Analyst is also dedicated to ensuring billing compliance for clinical research, supporting the Clinical Trial Management System (CTMS) Oncore. The analyst evaluates protocols, informed consent forms, budgets, and other study documents to generate protocol calendars in the CTMS and develop coverage analysis/billing grids. The analyst specifications which procedures and services qualify as ‘Routine Cost’ and may be billed to patient insurance, and which should be charged to the study. The analyst determines whether proposed studies meet the criteria for a Qualifying Clinical Trial per the Medicare Clinical Trial Policy (NCD 310.1). As part of the Research Systems & Coverage Analysis (RSCA) Unit, the analyst works to support and optimize clinical trial initiation and financial workflows with research teams and stakeholders.

Responsibilities

• 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 and coordinates compliance committee meetings.
• Performs other related work as needed.

Minimum Qualifications

Minimum requirements include a college or university degree in a related field.

Preferred Qualifications

• Education: Bachelor's degree.
• Experience: Clinical research experience such as clinical research conduct, regulatory compliance, or related research activities; coverage analysis experience.
• Preferred Competencies: 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; demonstrate attention to detail.

Working Conditions

• Office environment.

Pay

Scheduled Weekly Hours: 40

Pay Rate Type: Salary

FLSA Status: Exempt

Pay Range: $65,000.00 - $90,000.00

Benefits Eligible

Yes

Posting Statement

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.