Job Description
We are seeking an experienced Clinical Research Billing Specialist to join our Site Enabling Organization (SEO). This role is critical for ensuring accurate and compliant billing of clinical research activities from the site side, with particular attention to differentiating between research-related services and standard of care (SOC) services. The ideal candidate will have deep expertise in clinical trial financial operations, research billing compliance, and a thorough understanding of standard of care (SOC) billing practices. You will ensure proper invoicing of clinical trial services in accordance with contracts, while maintaining regulatory compliance.
Key Responsibilities:
- Billing Management: Oversee and manage billing processes for clinical research activities at the site, ensuring accurate billing of research-related services to sponsors and proper consideration related to site billing of standard of care (SOC) services to third-party payers (e.g., Medicare, private insurers).
- Budget Review & Development:
* Work with site staff, sponsors, and clinical research coordinators to review and negotiate clinical trial budgets, utilizes the research fee schedule to develop the per patient and pass through budgets for those billable items and services which cannot be billed to third party payers. Ensures that all costs and effort to conduct the study are appropriately covered within the study budget.
* Thoroughly reviews complex study protocols, Informed Consent Documents, draft sponsor Clinical Trial Agreements , and budgets to identify all billable items and services required of the study which might generate a CPT code. Documents the CPT codes at the respective visits for all billable items and services to be paid by the grant.
- Compliance Monitoring: Ensure all billing activities align with regulatory guidelines, including federal and state laws regarding clinical trial billing, Medicare regulations, and ethical billing practices.
- Invoice Generation & Reconciliation: Create and issue invoices to sponsors for research-related services per clinical trial agreements.
- Financial Reporting: Prepare detailed financial reports on billing activities, accounts receivable, and payment reconciliation for internal stakeholders and sponsors. Provide guidance to stakeholders to help them drive compliance with SOC requirements.
- Site Support: Provide training and guidance to research sites on distinguishing and appropriately billing standard of care services versus research-related services. Assist sites in understanding clinical trial agreements, budgets, and billing procedures.
- Data Management: Maintain accurate and organized financial records related to clinical trials in the billing system, ensuring that all research-related services are clearly tracked and documented.