[Hiring] Clinical Research Coverage Analyst @University of Chicago

Role Description

The job maintains regulatory compliance programs, including the interpretation of systems to identify areas of risk and may coordinate internal audits. With a moderate level of direction, participates in compliance documentation, compliance training, and compliance committee formation.

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.

Qualifications

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

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

Benefits

• The University of Chicago offers a wide range of benefits programs and resources for eligible employees, including health, retirement, and paid time off.