Senior Clinical Research Coverage Analyst

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 job uses best practices and knowledge for regulatory compliance program activities. Anticipates problems and develops systems to identify areas of risk through internal audits. Uses specialized expertise to manage compliance documentation submission and maintenance, compliance training, compliance committee formation, and other programmatic functions.

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. This role 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, 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 o