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 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 CTMS Support 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

• 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.

• Develop and audit study calendars within the Clinical Trial Management System, Oncore.

• Ensure consistency in the application of Medicare and other applicable rules across studies and alignment of study documents with billing regulations.

• 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.

• Communicate the results of coverage analyses to Principal Investigators and/or study teams, providing detailed explanations and addressing any questions or concerns.

• Onboard and train new clinical research staff to ensure adherence to billing compliance procedures.

• 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.

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.

• Abilit