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Compliance Analyst OR Senior Compliance Analyst, Clinical Research


Compliance Analyst OR Senior Compliance Analyst, Clinical Research

  • R0043173
  • Charlottesville, Virginia, United States
  • Protection, Compliance, and Regulation
  • The University of Virginia
The Clinical Research Office within the School of Medicine (SOM) is seeking a Compliance Analyst OR Senior Compliance Analyst. The position provides financial and budgetary expertise to clinical research staff, ensuring compliance with Centers for Medicare and Medicaid Services (CMS), federal, state, and institutional regulations governing clinical research billing. This position works directly with clinical research teams, the Office or Grants and Contracts, the Institutional Review Board, and billing and coding personnel of Patient Financial Services (PFS) and University Physician Group (UPG), to ensure compliance with the multiple layers of regulations governing clinical research billing.

Clinical Research Study Budget Duties:
  • Perform review of clinical research protocol, informed consent, and clinical trial agreement to assist study team in identifying costs for protocol-required tests/procedures (e.g., x-rays, lab tests), non-procedural charges (e.g., time and effort, IRB review charges, Investigational Drug Services charges, subject stipends, record retention), and applicable invoiceable services (e.g., SAE submissions, protocol amendments, auditing).
  • Assist study teams with the development of a clinical trial budget.

Billing Coverage Analysis (BCA) Duties:
  • Create study billing coverage analysis, specifying the intended direction of medical charges, complying with all applicable federal, and institutional regulations/policies, specifically the CMS National Coverage Decision (NCD) for research, as well as other third-party billing rules.
  • Update Billing Coverage Analysis, as applicable, when protocol or contract is modified in such a way that it impacts the billing of hospital/UPG charges.
  • Review research related injury language to ensure it complies with the institutional-required language.
  • Perform a cursory review of informed consents of protocols reviewed and approved by an outside IRB, reminding study teams that all local language agreed upon per the approved Reliance Agreement must be inserted.
  • Update and maintain workflow systems documenting completion of BCA.

Billing Performance of Clinical Research Protocol Duties:
  • Analyze protocol-driven clinical research services to ensure that both routine and research services are properly identified and billed in compliance with the CMS NCD.
  • Perform 2nd pass review in Epic of clinical charges associated with a specific study, ensuring charges are directed according to current Billing Coverage Analysis and in compliance with current federal regulations and institutional policies. Ensure compliance of research billing practices by reviewing Billing Coverage Analysis, fully executed clinical trial agreement, and IRB approved informed consent for congruency and accuracy.
  • Partner with UVA Health and UPG Revenue Cycle teams to correct any errors or misdirected billing.
  • Perform research billing reviews/audits to ensure compliance with all federal and institutional billing policies/procedures. Recommend corrective action that will address any identified deficiencies at the individual protocol level, the departmental level, as well as the institutional level.

Clinical Research Billing Process Training Duties:
  • Collaborate with clinical research coordinators, Principal Investigators, clinical departments, UVA Patient Financial Services (PFS), University Professional Group (UPG), and Clinical Research Office billing staff to identify training needs.
  • Develop and maintain training plans directed toward clinical research staff that will provide the training needed to ensure appropriate billing for clinical research charges.
  • Serve as a billing resource for clinical research staff.

Process Improvement Duties:
  • Collaborate closely with Director of the Clinical Research Office to identify opportunities for improvements in clinical research billing practices.
  • Assist with the development of policies and procedures, monitor key performance indicators, and supervise routine and special projects related to clinical research budget and billing


Compliance Analyst:

Education: Bachelor's degree. 4 years of relevant experience may be considered in lieu of a degree.
Experience: At least two years of relevant experience

Senior Compliance Analyst:
Education: Bachelor's degree. 4 years of relevant experience may be considered in lieu of a degree.
Experience: Four years of relevant experience
Licensure: Subject matter licensure may be required

  • Four years of clinical research experience
  • Knowledge of CMS and FDA regulations as they relate to clinical research
  • Knowledge of HIPPA and other relevant clinical research regulations
  • Familiar with Federal Anti-Kickback laws
  • Research certification such as CCRA, CCRC or CCRP

This is primarily a sedentary job involving extensive use of desktop computers. The job does occasionally require traveling some distance to attend meetings, and programs.

This is a restricted position and is dependent upon project need, availability of funding and performance. This is an EXEMPT level, benefited position. For more information on the benefits at UVA, visit https://hr.virginia.edu/benefits .

This position will remain open until filled. The University will perform background checks on all new hires prior to employment. A completed pre-employment health screen is required for this position prior to employment.


Please apply through Workday , and search for R0043173. Internal applicants must apply through their UVA Workday profile by searching 'Find Jobs'. Complete an application online with the following documents:
  • CV or Resume
  • Cover letter

Upload all materials into the resume submission field, multiple documents can be submitted into this one field. Alternatively, merge all documents into one PDF for submission. Applications that do not contain all required documents will not receive full consideration.

References will be completed via UVA’s standardized process Skill Survey during the final phase of the interview process.

For questions about the application process, please contact Jeremy Brofft, Senior Recruiting Specialist at xmf9ad@virginia.edu .

For more information about UVA and the Charlottesville community please see http://www.virginia.edu/life/charlottesville and https://embarkcva.com/ .

COVID Vaccination Requirement and Guidelines

Please visitthe UVA COVID-19 Job Requirements and Guidelines webpageprior to applying for current information regarding vaccination requirementsandguidelines for employment at UVA.

The University of Virginia, i ncluding the UVA Health System which represents the UVA Medical Center, Schools of Medicine and Nursing, UVA Physician’s Group and the Claude Moore Health Sciences Library, are fundamentally committed to the diversity of our faculty and staff. We believe diversity is excellence expressing itself through every person's perspectives and lived experiences. We are equal opportunity and affirmative action employers. All qualified applicants will receive consideration for employment without regard to age, color, disability, gender identity or expression, marital status, national or ethnic origin, political affiliation, race, religion, sex (including pregnancy), sexual orientation, veteran status, and family medical or genetic information.


Each agency within the Commonwealth of Virginia is dedicated to recruiting, supporting, and maintaining a competent and diverse work force. Equal Opportunity Employer

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