Clinical Trial Budget Analyst

Sutter Health•Sacramento, CA

10d

About The Position

The Clinical Trial Budget Analyst determines whether a study qualifies as a clinical trial and performs initial coverage analysis of protocol-specific clinical 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 determines and documents billing support for clinical items by reviewing research protocols, investigator brochures, sponsor budgets and proposed contracts, consent templates, medical-necessity justifications, and appropriate payers for protocol-specific services. The role identifies federally required research-related claims modifications and conducts final reviews to ensure study documents are harmonized. It interprets Medicare and Medicaid coverage decisions and relevant national guidelines, and supports CPT/HCPCS billing determinations by applying applicable coverage decisions and third-party payer rules. The position works with Sutter Health research affiliates, administrative staff, principal investigators, essential partners, and clinical trial sponsors on reimbursement for research services. It supports an integrated approach to standardizing administrative and financial support for clinical-trial billing compliance, service to the research community, and 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, and national medical practice guidelines.
Knowledge of FDA investigational drug and device research.
Knowledge of medical coding, protocol visit span allowances, protocol-specified clinical services, research-study demographics, clinical research financial activities, and documentation required before study initiation.
Demonstrated written, oral, electronic communication, presentation, and interpersonal skills.
Ability to use multiple technical systems as intended and collaborate across revenue cycle, compliance, and research operations teams.
Attention to detail, analytical skills, and computer skills, including proficiency in Microsoft Word, Outlook, and Excel.
Ability to work independently and take responsibility for complex and sensitive decision-making.
Strong organizational skills to manage competing timetables and responsibilities.
Demonstrated leadership, team-building, and coaching or mentoring skills, including 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 research institute personnel.

Responsibilities

Determine whether a study qualifies as a clinical trial.
Perform initial coverage analysis 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 a notification of participation letter to Noridian (MAC) when needed.
Review protocols, investigator brochures, sponsor budgets and proposed contracts, consent templates, medical-necessity justifications, and payer information to determine and document billing support for clinical items.
Identify appropriate payers for protocol-specific services and federally required research-related claims modifications for insurance payment.
Conduct final reviews and analysis of study documents to ensure study-related documents are harmonized.
Interpret Medicare and Medicaid coverage decisions and national guidelines as they apply to clinical-trial medical items and services.
Support CPT/HCPCS billing determinations for clinical-trial items and services, applying applicable local and national coverage determinations and third-party payer rules.
Interface with Sutter Health research affiliates, administrative staff, principal investigators, essential partners, and clinical-trial sponsors regarding reimbursement for research services.
Support standardized administrative and financial functions for clinical-trial billing compliance and research operations.