Clinical Trial Coverage & Compliance Analyst

University of Chicago; Chicago (IL); On-site; USD 65,000 - 90,000; Full time

Job summary

The University of Chicago Office of Clinical Research seeks a Coverage Analyst to maintain regulatory compliance programs, interpret systems for risk, and coordinate internal audits. The analyst develops coverage analyses, billing grids, and Oncore CTMS calendars, ensuring Medicare rules are applied consistently across studies.

Collaborating with HRPP and research units, the role supports and optimizes clinical trial initiation and financial workflows with research teams and stakeholders.

Qualifications

• Minimum requirements include a college or university degree in a related field.
• Bachelor's degree is preferred for this role.
• Experience in clinical research, regulatory compliance, or related activities; coverage analysis experience preferred.

Responsibilities

• Reviews 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.
• Collaborates with HRPP and research units to harmonize regulatory and budgetary processes in clinical trials.
• Communicates the results of coverage analyses to principal investigators and study teams, addressing questions or concerns.
• Ensures 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 compliance with a moderate level of guidance.
• Prepares, completes and submits all compliance documentation and coordinates compliance committee meetings.
• Performs other related work as needed.

Skills

Billing compliance

Oncore CTMS

Regulatory compliance

Coverage analysis

Budget review

Audits

Education

Bachelor's degree

Tools

OnCore CTMS

Excel

Job description

The University of Chicago Office of Clinical Research seeks a Coverage Analyst to maintain regulatory compliance programs, interpret systems for risk, and coordinate internal audits. The analyst develops coverage analyses, billing grids, and Oncore CTMS calendars, ensuring Medicare rules are applied consistently across studies.

Collaborating with HRPP and research units, the role supports and optimizes clinical trial initiation and financial workflows with research teams and stakeholders.