Indiana University - Indianapolis, IN
posted 4 months ago
The Coverage Analyst (Research Compliance Consultant) at Indiana University plays a crucial role within the Office of Clinical Research (OCR), which serves as the single point of entry for clinical research studies across the university. This position is designed for a developing analyst who is gaining skills in research compliance consulting, research billing processes, project management, and other essential competencies needed to be an effective member of the Financial Compliance Team. The Coverage Analyst will perform assignments in accordance with current standard operating procedures (SOPs) and collaborate closely with the Financial Compliance Team and OCR leadership. In this role, the Coverage Analyst will act as a liaison with other research administrators to support and facilitate the activation of clinical research studies, budget development, informed consent review, and guidance, as well as navigation of the OnCore clinical trial management system. Building effective and cooperative relationships within the Financial Compliance Team and with collaborators in contracting, Institutional Review Board (IRB), departmental, and other administrative research units is essential. The Coverage Analyst will review clinical trial proposals and protocols to determine if each new study qualifies as a clinical trial under the Centers for Medicare & Medicaid Services (CMS) policy. This includes creating coverage analyses and billing plans for each clinical trial in accordance with Medicare rules and performing document reviews to ensure alignment for each study. The analyst will also assess compliance with other regulatory requirements, including those from the Food and Drug Administration (FDA) and the National Institutes of Health (NIH). Participation in study-specific team meetings is expected to foster relationships with research teams and administrators, supporting the activation of clinical research studies. The Coverage Analyst will assist with Clinical Research Financial Compliance special projects as needed and maintain required competencies and current knowledge in relevant research billing rules and guidance, database management, Outlook, and Excel. Identifying needs and reporting issues concerning regulatory compliance and financial stability is a key responsibility, as errors in processes could impact the financial stability of research projects. The analyst will be part of the Financial Compliance Team, ensuring compliance with federal regulations and the financial prudence of the university, as errors could affect the fiscal viability of the clinical research enterprise.