Clinical Research Coverage Analyst

Clinical Research Coverage Analyst

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: Minimum requirements include knowledge and skills developed through 2-5 years of work experience in a related job discipline.

Preferred Qualifications

• 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

Legal & Regulatory Affairs

Role Impact

Individual Contributor

Scheduled Weekly Hours

40

Pay Rate Type

Salary

?FLSA Status

Exempt

?Pay Range

$65,000.00 - $90,000.00

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 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.

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