Lead Compliance Officer for Clinical Research

1 week ago

Charlottesville, Virginia, United States Commonwealth of Virginia Full time
Position Overview
The Commonwealth of Virginia is seeking a Senior Compliance Manager for Clinical Research to oversee the financial services related to clinical trials. This role is crucial in ensuring that clinical research teams receive comprehensive budget and billing support, including the development of clinical trial budgets, billing coverage analysis, and sponsor invoicing. The Senior Compliance Manager will lead a dedicated team focused on financial compliance with all relevant regulations.

Key Responsibilities
  • Develop and maintain a comprehensive program to provide oversight, education, and support for all departments involved in clinical research budgeting and billing, ensuring adherence to applicable laws and policies.
  • Stay informed on CMS and FDA regulations pertinent to Medicare coverage analysis and other regulations governing clinical trials, including Federal Anti-Kickback laws and HIPAA.
  • Assist research teams in formulating clinical trial budgets by reviewing protocols, informed consents, and agreements to identify necessary costs.
  • Supervise staff responsible for conducting billing coverage analyses, ensuring compliance with federal and institutional regulations.
  • Oversee the review of clinical charges in Epic, ensuring alignment with current billing coverage analyses and compliance with regulations.
  • Manage the invoicing process for sponsors upon the completion of clinical trial billing milestones.
  • Maintain a personal budget portfolio and provide backup support for billing staff as necessary.
  • Conduct audits of research billing to ensure compliance with all federal and institutional policies, recommending corrective actions as needed.
  • Collaborate with internal stakeholders to assess training needs and develop training programs for clinical research staff.
  • Create and maintain a charge master for non-medical clinical research services.
  • Assist in developing metrics for ongoing assessment and transparency in billing practices.
  • Work closely with the budget and billing team to identify opportunities for improvement in clinical research billing practices.
  • Contribute to the development of policies and procedures, monitor key performance indicators, and supervise projects related to clinical research budget and billing.
Minimum Qualifications
  • Education: Bachelor's degree required.
  • Experience: Minimum of eight years of relevant experience.
  • Licensure: Subject matter licensure may be necessary.
Preferred Qualifications
  • Four years of experience in clinical research.
  • Management or supervisory experience.
  • Experience with clinical research budgets and billing processes.
  • Knowledge of CMS regulations, FDA regulations, Federal Anti-Kickback laws, and HIPAA.
  • Research certification such as CCRA, CCRC, or CCRP is advantageous.
Physical Demands
This position primarily involves sedentary work with extensive use of desktop computers. Occasional travel may be required for meetings and programs.

Application Process
Interested candidates should apply through the designated application platform, ensuring that all required documents are submitted for consideration.

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