Senior Compliance Manager, Clinical Research

3 weeks ago

Charlottesville, Virginia, United States Commonwealth of Virginia Full time
Job Title: Clinical Research Compliance Manager

Job Summary:
The Commonwealth of Virginia is seeking a Clinical Research Compliance Manager to manage the clinical research financial services provided by the SOM Clinical Trials Office. The SOM CTO provides budget and billing support to clinical research teams such as clinical trial budget development, study billing coverage analysis development, Epic billing reconciliation, and sponsor invoicing. The clinical research budget and billing team 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.

Key Responsibilities:
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

Requirements:
Bachelor's degree
At least eight years of relevant experience.
Subject matter licensure may be required.

Preferred Qualifications:
4 years of clinical research experience.
Management/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 R0055427. 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.

  • Senior Compliance Manager, Clinical Research

    4 weeks ago

    Charlottesville, Virginia, United States Commonwealth of Virginia Full time

    Job SummaryThe Commonwealth of Virginia's School of Medicine Clinical Trials Office is seeking a Clinical Research Senior Compliance Manager to manage the clinical research financial services provided by the SOM Clinical Trials Office. The SOM CTO provides budget and billing support to clinical research teams, ensuring compliance with Centers for Medicare...

  • Clinical Research Manager

    4 weeks ago

    Charlottesville, Virginia, United States Commonwealth of Virginia Full time

    Job SummaryThe Department of Obstetrics and Gynecology at the University of Virginia is seeking a highly skilled Clinical Research Manager to lead the development and management of clinical research programs in two divisions: GynOnc and Benign Gyn. This is an exempt level, benefited position that requires a strong background in clinical research, leadership,...

  • Clinical Research Nurse

    3 weeks ago

    Charlottesville, Virginia, United States Virginia Jobs Full time

    Job SummaryThe SOM Clinical Trials Office is seeking a Research Nurse to provide nursing care to research subjects seen at the SOM Clinical Research Units. This is a part-time PRN position, with hours determined by staffing needs.Key ResponsibilitiesProvide care to research subjects, working closely with study subjects, the Principal Investigator (PI), and...

  • Clinical Research Coordinator

    4 weeks ago

    Charlottesville, Virginia, United States Commonwealth of Virginia Full time

    Job SummaryWe are seeking a highly skilled Clinical Research Coordinator to join our team at the Nephrology Clinical Research Center. The successful candidate will be responsible for coordinating all aspects of clinical research from study start-up through archiving of study records.Key ResponsibilitiesAssist with regulatory, financial, and logistical...

  • Clinical Research Nurse

    4 weeks ago

    Charlottesville, Virginia, United States Virginia Jobs Full time

    Job SummaryWe are seeking a skilled Clinical Research Nurse to provide high-quality patient care and support research studies at our Clinical Research Units.The ideal candidate will have a strong background in nursing and research, with excellent communication and interpersonal skills.This is a part-time PRN position, with hours determined by staffing...

  • Clinical Research Nurse

    3 weeks ago

    Charlottesville, Virginia, United States Virginia Jobs Full time

    The Virginia Jobs Clinical Trials Office is seeking a skilled Clinical Research Nurse to provide high-quality nursing care to research subjects at our state-of-the-art Clinical Research Units.As a Clinical Research Nurse, you will work closely with the Principal Investigator (PI), study team, and research subjects to deliver effective patient care in...

  • Clinical Research Coordinator 4 Lead

    4 weeks ago

    Charlottesville, Virginia, United States Commonwealth of Virginia Full time

    Job SummaryThe Department of Pediatrics at the University of Virginia's School of Medicine is seeking a Clinical Research Coordinator 4 Lead to join their dynamic research team. As a key member of the team, you will be responsible for overseeing clinical research efforts, managing multiple complex trials, and ensuring compliance with regulatory...

  • Clinical Research Financial Coordinator

    3 weeks ago

    Charlottesville, Virginia, United States Commonwealth of Virginia Full time

    Clinical Research Financial Coordinator Job DescriptionThe Commonwealth of Virginia's Office of Clinical Research is seeking a highly skilled Clinical Research Financial Coordinator to join their team. This role will be responsible for developing budgets for clinical trials, working on systems for making internal payments for trial expenses, and billing...

  • Clinical Research Coordinator

    3 weeks ago

    Charlottesville, Virginia, United States Commonwealth of Virginia Full time

    Job Title: Clinical Research CoordinatorAbout the Job:The Division of Cardiovascular Medicine at the University of Virginia's School of Medicine is seeking a Clinical Research Coordinator to join their team. As a Clinical Research Coordinator, you will play a critical role in the success of research studies, working closely with physicians, research staff,...

  • Clinical Research Financial Coordinator

    4 weeks ago

    Charlottesville, Virginia, United States Commonwealth of Virginia Full time

    Clinical Research Financial CoordinatorThe Commonwealth of Virginia's Cancer Center Office of Clinical Research is seeking a highly skilled Clinical Research Financial Coordinator to join their team. This role will play a critical part in developing budgets for clinical trials and ensuring compliance with regulations governing clinical research billing.Key...

  • Clinical Research Coordinator, Varying Levels

    3 weeks ago

    Charlottesville, Virginia, United States The Rector & Visitors of the University of Virginia Full time

    The Division of Cardiovascular Medicine at the University of Virginia's School of Medicine is seeking a Clinical Research Coordinator to join their dynamic team of clinical research professionals. This position is open to applicants who meet the requirements of Clinical Research Coordinator 1, 2, 3, and 4.The successful candidate will be responsible for...

  • Nursing Director

    4 weeks ago

    Charlottesville, Virginia, United States Sunrise Senior Living Full time

    About the Role:The Resident Care Director is a key member of the Sunrise Senior Living team, responsible for leading and managing the health and wellness of residents in our community. This role requires a strong clinical background, excellent leadership skills, and a passion for delivering high-quality care.Key Responsibilities:Provide strategic leadership...

  • Regulatory Clinical Research Coordinator

    3 weeks ago

    Charlottesville, Virginia, United States Commonwealth of Virginia Full time

    Regulatory Clinical Research CoordinatorThe Commonwealth of Virginia's Office of Clinical Research is seeking a highly skilled Regulatory Clinical Research Coordinator to join their team. As a key member of the team, the successful candidate will be responsible for ensuring the efficient and compliant regulatory management of clinical research protocols...

  • Senior Public Health Researcher

    2 weeks ago

    Charlottesville, Virginia, United States Commonwealth of Virginia Full time

    Job SummaryWe are seeking a highly qualified Senior Research Specialist to join our team in the Department of Public Health Sciences at the Commonwealth of Virginia. This is a 12-month appointment with the possibility of renewal contingent upon satisfactory performance and the availability of funding.Job ResponsibilitiesManage a research program spanning...

  • Clinical Veterinarian

    3 weeks ago

    Charlottesville, Virginia, United States The Rector & Visitors of the University of Virginia Full time

    Job SummaryThe Center for Comparative Medicine at the University of Virginia seeks a qualified Clinical Veterinarian to oversee the clinical veterinary care program for research animals. The successful candidate will provide expert clinical case management, treatment, and knowledge of various laboratory animal species.Key ResponsibilitiesDeliver expert...

  • Clinical Research Coordinator, Psychiatry

    3 weeks ago

    Charlottesville, Virginia, United States Virginia Jobs Full time

    The Department of Psychiatry and Neurobehavioral Sciences at UVA School of Medicine is seeking a Clinical Research Coordinator (CRC) to join the Reproductive Psychiatry Research Program (RPRP) team. The CRC will work closely with an experienced CRC and/or Principal Investigator to learn the full scope of clinical research duties.Key Responsibilities:Identify...

  • Clinical Research Coordinator 2-4/Nurse

    3 weeks ago

    Charlottesville, Virginia, United States The Rector & Visitors of the University of Virginia Full time

    The University of Virginia's Center for Diabetes Technology is seeking a skilled Clinical Research Coordinator to join their team. As a key member of the research team, you will be responsible for coordinating and implementing clinical trial research studies, working closely with Principal Investigators, Operational Managers, and other research team...

  • Clinical Veterinarian

    3 weeks ago

    Charlottesville, Virginia, United States The Rector & Visitors of the University of Virginia Full time

    The Center for Comparative Medicine at the University of Virginia seeks a qualified Clinical Veterinarian to provide expert clinical case management, treatment, and knowledge of various laboratory animal species. The successful candidate will deliver high-quality care, provide surgical support, and evaluate newly arrived animals. Additionally, the Clinical...

  • Senior Systems Engineer

    3 weeks ago

    Charlottesville, Virginia, United States Commonwealth Computer Research Full time

    Job SummaryCommonwealth Computer Research is seeking a highly skilled Senior Systems Engineer to join our team. As a key member of our national/tactical systems team, you will be responsible for designing, integrating, and maintaining complex command and control, situational awareness, and battle management systems across multiple domains.Key...

  • Regulatory Compliance Specialist

    4 weeks ago

    Charlottesville, Virginia, United States Commonwealth of Virginia Full time

    Job SummaryThe School of Medicine Clinical Trials Office is seeking a highly skilled Regulatory Compliance Coordinator to join their team. As a key member of the team, you will be responsible for ensuring the efficient and compliant regulatory management of clinical research protocols.Key ResponsibilitiesPrepare and submit regulatory documents to...