Senior Clinical Research Coverage Analyst

University of Chicago • Full-time • Franklin McLean Research Institute, United States of America • 2m ago

Department

BSD OCR - CTMS Support Unit

About the Department

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.

Job Summary

The Senior Clinical Research Coverage Analyst is dedicated to ensuring billing compliance for clinical research and supports utilization of the Clinical Trial Management System (CTMS). The Coverage Analyst 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 guide. The Coverage 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 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 CTMS Support Unit within the Office of Clinical Research, the Coverage Analysts 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

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 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 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.
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.
Acts as a leader within the department/unit through improving coverage analysis practice; serves as a resource person or acts as a consultant within area of expertise.
Develops and implements procedures, maintains records, tracks progress, and conducts quality assurance checks on work products produced.
Performs various professional, organizational, and operational tasks under limited supervision. Acts as a resource on clinical research and related aspects of clinical study for other clinical research staff. Accountable for complex problem solving on assigned studies and professional tasks.
Guides the implementation of compliance activities designated by the University's strategic plans. Monitors University compliance with regulations and laws.
Represents the University in regulatory proceedings before federal, state and local agencies. Prepares the University's position statements and responses to information requests.
Performs other related work as needed.

Minimum Qualifications

Education:

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

Work Experience:

Minimum requirements include knowledge and skills developed through 5-7 years of work experience in a related job discipline.

Certifications:

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Preferred Qualifications

Education:

College or university degree in related field.

Experience:

Clinical research experience such as clinical research conduct, regulatory compliance, or related research activities.
Coverage analysis experience.

Technical Skills or Knowledge:

Proficiency with computer software systems such as Clinical Trial Management Systems.
Proficient with medical technology.
Proficient with interpretation of Medicare’s Clinical Trial Policy (NCD 310.1), CMS (Centers for Medicare & Medicaid Services) Billing Guidelines, & NCCN (National Comprehensive Cancer Network Guidelines) guidelines.
Knowledge of relevant FDA regulations affecting coverage decisions.

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.
Demonstrated attention to detail.

Working Conditions

Office Environment.

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

Legal & Regulatory Affairs

Role Impact

Individual Contributor

Scheduled Weekly Hours

Drug Test Required

Health Screen Required

Motor Vehicle Record Inquiry Required

Pay Rate Type

Salary

FLSA Status

Exempt

Pay Range

$80,000.00 - $110,000.00

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

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 theBenefits 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.

The University of Chicago's Annual Security & Fire Safety Report (Report) provides information about University offices and programs that provide safety support, crime and fire statistics, emergency response and communications plans, and other policies and information. The Report can be accessed online at: http://securityreport.uchicago.edu. Paper copies of the Report are available, upon request, from the University of Chicago Police Department, 850 E. 61st Street, Chicago, IL 60637.

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