Clinical Trial Budget Analyst
About The Position
The Clinical Trial Budget Analyst determines whether studies qualify as clinical trials and conducts initial coverage analyses of research protocol services to support federally compliant billing and reimbursement. The role ensures required documents are submitted to conduct a coverage analysis and activate a study, and submits a notification of participation letter to Noridian (MAC) when needed. The analyst reviews protocols, investigator brochures, sponsor budgets and proposed contracts, consent templates, medical-necessity justifications, and payer responsibilities for protocol-specific services. The role documents billing support and required research-related claims modifications, and performs final reviews to confirm that study documents are harmonized. It interprets Medicare and Medicaid coverage decisions and applicable guidelines, supports CPT/HCPCS billing determinations, and applies local and national coverage determinations and third-party payer rules to clinical-trial coverage analyses. The position interfaces with Sutter Health research affiliates, administrative staff, principal investigators, essential partners, and clinical-trial sponsors regarding reimbursement for research services. It helps standardize administrative and financial support for clinical-trial billing compliance, improving service to the Sutter Health research community and supporting research compliance.
Requirements
- Bachelor’s degree or equivalent education/experience.
- Five years of recent relevant experience.
- Demonstrated knowledge of clinical research concepts, good clinical practices, and regulatory compliance.
- Knowledge of Medicare benefit categories, statutory exclusions, national and local coverage determinations, national medical-practice guidelines, and FDA investigational drug and device research.
- Knowledge of medical coding, protocol visit span allowances, protocol-specified clinical services, research-study demographics, and financial activities and documentation required before study initiation.
- Demonstrated written, oral, and electronic communication, presentation, and interpersonal skills.
- Ability to use multiple technical systems, collaborate across revenue cycle, compliance, and research operations teams, and maintain attention to detail.
- Analytical and computer skills, including proficiency in Microsoft Word, Outlook, and Excel.
- Ability to work independently and take responsibility for complex and sensitive decisions.
- Strong organizational skills to manage competing timetables and responsibilities.
- Demonstrated leadership, team-building, and coaching or mentoring skills, with the ability to motivate and engage others.
- Ability to establish effective working partnerships with employees, peers, and leaders to achieve business objectives.
- Organizational and time-management skills, including prioritizing multiple projects while delivering quality service and achieving business results.
- Tactical and analytical thinking and planning skills, including developing plans, identifying obstacles, and resolving operational issues.
- Demonstrated ability to communicate and collaborate with Sutter Health essential partners, including Legal Services, ECS, and SHIRB, and with research institute personnel.
Responsibilities
- Determine whether a study qualifies as a clinical trial.
- Perform initial coverage-analysis reviews of research protocol clinical services to support federally compliant billing and reimbursement.
- Ensure required documents are submitted to conduct coverage analysis and activate a study.
- Submit notification of participation letters to Noridian (MAC) when needed.
- Review protocol and study documents, including investigator brochures, sponsor budgets and proposed contracts, consent templates, and medical-necessity justifications.
- Determine and document billing support, payer responsibility for protocol-specific services, and required research-related claims modifications.
- Conduct final reviews to ensure study-related documents are harmonized.
- Interpret Medicare and Medicaid coverage decisions and applicable national guidelines for clinical-trial medical items and services.
- Support CPT/HCPCS billing determinations and apply applicable local and national coverage determinations and third-party payer rules.
- Interface with research affiliates, administrative staff, principal investigators, essential partners, and sponsors regarding reimbursement for research services.
- Help standardize administrative and financial support functions for clinical-trial billing compliance.
Benefits
- Comprehensive benefits package for eligible positions.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
