Department
BSD OCR - CTMS Support Unit
About the Department
The 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.
Job Summary
The Clinical Research Coverage Analyst is dedicated to ensuring billing compliance for clinical research and supports utilization of the Clinical Trial Management System (CTMS). This team member plays a crucial role in evaluating clinical research protocols, Informed Consent Forms, Clinical Trial Agreements, and other pertinent study documents to generate a protocol calendar in the CTMS system and develop coverage analysis/billing grid.
The Analyst specifies which medical procedures and services may qualify as 'Routine Cost' and be billable to patient insurance, and which should be charged to the study. The Analyst is responsible for determining whether proposed clinical research studies meet the criteria for a Qualifying Clinical Trial as defined by CMS.
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.
Responsibilities
Coverage Analysis Creation: Review clinical trial protocols, budgets, contracts, and informed consent documents to determine billing compliance. Create detailed coverage analyses that outline the billing of clinical items and services required by research studies.
CTMS Build: Develop and audit study calendars within the Clinical Trial Management System, Oncore.
Regulatory Compliance: Ensure consistency in the application of Medicare and other applicable rules across studies and alignment of study documents with billing regulations.
Collaboration: Work collaboratively with key offices, including the Human Research Protection Program, the Clinical Trial Financial Group and research units, to harmonize regulatory and budgetary processes in clinical trials.
Communication: Communicate the results of coverage analyses to Principal Investigators and/or study teams, providing detailed explanations and addressing any questions or concerns.
Training and Development: Onboard and train new clinical research staff to ensure adherence to billing compliance procedures.
Additional Duties: Complete other duties as assigned by management to support the mission of the Office of Clinical Research.
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.
Minimum Qualifications
Education:
Minimum requirements include a college or university degree in related field.
Work Experience:
Certifications:
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Preferred Qualifications
Experience:
Clinical research experience such as clinical research conduct, regulatory compliance, or related research activities.
Coverage analysis experience.
Clinical Trial Management System utilization.
Preferred Competencies
Ability to interpret research protocols, budgets, and consent forms to extrapolate billing/coverage information.
Ability to interpret NCCN guidelines.
Ability to audit work products and provide guidance and feedback.
Knowledge of relevant Federal and state regulations.
Ability to problem solve, leveraging information and expertise available.
Proficiency with computer software systems such as Clinical Trial Management System.
Strong organizational skills.
Ability to manage projects at various stages of completion.
Ability to manage high volume of workload and meet deadlines.
Demonstrated attention to detail.
Working Conditions
Fully Remote.
Application Documents
Resume (required)
Cover Letter (preferred)
When applying, the document(s) MUST be uploaded via the My Experience page, in the section titled Application Documents of the application.
Job Family
Role Impact
Scheduled Weekly Hours
Drug Test Required
Health Screen Required
Motor Vehicle Record Inquiry Required
Pay Rate Type
FLSA Status
Pay Range
The included pay rate or range represents the University’s good faith estimate of the possible compensation offer for this role at the time of posting.
Benefits Eligible
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.
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.
Job seekers in need of a reasonable accommodation to complete the application process should call 773-702-5800 or submit a request via Applicant Inquiry Form.
All offers of employment are contingent upon a background check that includes a review of conviction history. A conviction does not automatically preclude University employment. Rather, the University considers conviction information on a case-by-case basis and assesses the nature of the offense, the circumstances surrounding it, the proximity in time of the conviction, and its relevance to the position.
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Skills Required
- College or university degree in a related field
- 2-5 years of relevant work experience in clinical research, compliance, or related discipline
- Experience creating coverage analyses and billing grids for clinical research
- Experience using a Clinical Trial Management System (Oncore/CTMS)
- Ability to interpret research protocols, informed consent forms, budgets, and clinical trial agreements for billing purposes
- Knowledge of Medicare/CMS billing rules and relevant federal/state regulations
- Experience auditing study calendars and providing feedback/guidance
- Strong organizational skills, attention to detail, and ability to manage high volumes and deadlines
What We Do
The University of Chicago is an urban research university that has driven new ways of thinking since 1890. Our commitment to rigorous inquiry and intellectual freedom draws pathbreaking scholars to our global campuses, where field-defining ideas are born that challenge and change the world. The University of Chicago has its main campus on Chicago's South Side and seven international campuses and centers throughout the world. Students can choose from 53 majors and 47 minors in the undergraduate College, with four divisions and seven professional schools for graduate study.
