Senior Compliance Manager, Clinical Research
6 days ago
Job Description
Manage and maintain a program to provide oversight, education, and ongoing support to all areas of UVA involved in clinical research budgeting and billing to facilitate compliance with all relevant laws, regulations, and policies. Maintain understanding of CMS and FDA regulations relevant to Medicare coverage analysis, as well as other regulations pertaining to conducting a clinical trial, including Federal Anti-Kickback laws, HIPAA, and other relevant regulations. Assist study teams with the development of clinical trial budgets. Review clinical research protocol, informed consent and clinical trial agreement to assist study team in identifying costs for protocol-required tests/procedures, non-procedural charges, and applicable invoiceable services. Assist with negotiation of budget as requested. Manage staff who assist study teams with the completion of the 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. Manage staff who 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. Manage process for invoicing sponsors when clinical trial billing milestones are met. Manage own budget portfolio and serve as back up for billing staff when needed. 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. Collaborate with internal stakeholders to identify training needs. Develop and maintain training plans/programs directed toward clinical research staff that will provide the training needed to ensure appropriate billing for clinical research charges. Create and maintain a clinical research charge master for non-medical clinical research services. Assist with the development of metrics for continual assessment and transparency. Collaborate closely with budget and billing team, CTO team members, internal stakeholders and the Director of the Trials 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 MINIMUM REQUIREMENTS
Education: Bachelor's degree
Experience: At least eight years of relevant experience.
Licensure: Subject matter licensure may be required.
Preferred Qualifications:
4 years of clinical research experience. M anagement/supervisory experience. Experience with clinical research budgets and billing. Knowledge of CMS regulations, FDA regulations, Federal Anti-Kickback laws, HIPAA and other relevant clinical research regulations. Research certification such as CCRA, CCRC or CCRP. PHYSICAL DEMANDS
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.
Anticipated Hiring Range: starting at $95,000 commensurate with education and experience.
This is a restricted position and is dependent upon project need, availability of funding and performance. For more information on the benefits at UVA, visit . 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.
TO APPLY
Please apply through Careers at UVA , and search for R 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 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 .
For more information about UVA and the Charlottesville community please see and .
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.
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