Senior Compliance Manager, Clinical Research

2 days ago

Charlottesville, Virginia, United States Commonwealth of Virginia Full time
Job Summary

The 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 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, reviewing clinical research protocol, informed consent, and clinical trial agreement to assist study teams in identifying costs for protocol-required tests/procedures, non-procedural charges, and applicable invoiceable services.
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, recommending corrective action to address any identified deficiencies at the individual protocol level, the departmental level, and the institutional level.
Collaborate with internal stakeholders to identify training needs, developing and maintaining training plans/programs directed toward clinical research staff to 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, monitoring key performance indicators, and supervising 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 include 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, and research certification such as CCRA, CCRC, or CCRP.

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