Clinical Trials Billing & Regulatory Oversight Specialist

Vanderbilt University Medical Center; Nashville (TN); Remote; USD 100,000 - 140,000; Full time

Job summary

Vanderbilt University Medical Center seeks a Regulatory Oversight Specialist – Research to plan and lead projects ensuring the integrity of billing for clinical research and trial-related activities. You will drive CMS compliance reviews, auditing Medicare Coverage Analysis, and charge segregation across studies, with autonomy and executive-level reporting.

The role requires a Bachelor’s degree with 10 years of relevant experience; CHRC/CHC preferred.

Qualifications

• Bachelor’s Degree and 10 years of relevant work experience in a Large Academic Medical Center.
• CHRC (Certification in Healthcare Research Compliance) and/or CHC (Certified in Healthcare Compliance) preferred.
• Familiarity with OnCore Clinical Trials Management System strongly preferred.

Responsibilities

• Lead prospective and retrospective reviews of study protocols, billing grid development and research charge segregation functions.
• Analyze compliance with CMS regulations for billing of research studies and clinical registries by auditing Medicare Coverage Analysis, Coverage with Evidence Development (CED) guidelines, medical documentation in EPIC, and insurance and patient billing and collection transactions.
• Perform special projects related to compliance matters as requested by Office of Compliance and Corporate Integrity and/or Office of Legal Counsel.
• Analyze data files in Excel to evaluate compliance with criteria under review and document findings and key recommendations in a clear and concise manner.
• Lead complex financial, operational, reimbursement, and business analyses.
• Interpret and communicate analytical findings and recommendations to leadership.
• Present key findings and recommendations to executive level management.
• Support legal, compliance and research administration leadership, and finance committee reporting requirements.
• Lead initiatives to improve CMS regulatory oversight monitoring and control processes.
• Evaluate clinical trials management systems, workflows, and reporting tools and recommend enhancements.
• Promote standardization and best practices across enterprise financial processes.
• Identify opportunities to leverage technology, automation, and analytics to improve effectiveness.

Skills

Regulatory analysis

CMS regulations

Data analysis in Excel

PowerPoint presentations

Project leadership

Education

Bachelor's degree

CHRC/CHC preferred

Tools

OnCore

Job description

Vanderbilt University Medical Center seeks a Regulatory Oversight Specialist – Research to plan and lead projects ensuring the integrity of billing for clinical research and trial-related activities. You will drive CMS compliance reviews, auditing Medicare Coverage Analysis, and charge segregation across studies, with autonomy and executive-level reporting.

The role requires a Bachelor’s degree with 10 years of relevant experience; CHRC/CHC preferred.