Clinical Research Coverage Analyst

Sanford Health is one of the largest and fastest-growing not-for-profit health systems in the United States. Were proud to offer many development and advancement opportunities to our nearly 50000 members of the Sanford Family who are dedicated to the work of health and healing across our broad footprint.

Work Shift:

8 Hours - Day Shifts (United States of America)

Scheduled Weekly Hours:

40

Salary Range: $24.00 - $38.50

Union Position:

No

Department Details

Summary

The Clinical Research Coverage Specialist/Analyst is responsible for conducting accurate and timely Medicare Coverage Analyses (MCA) for clinical research studies with a primary focus on oncology trials specialty trials and investigator-initiated trials (IITs) within an integrated health system. This role ensures compliance with federal and institutional billing regulations promotes financial integrity in clinical research and supports effective trial startup and management. This role may be hybrid or remote from specific states. Occasional on-site presence may be required for meetings audits or training.

Job Description

Key Responsibilities:

• Perform detailed Medicare Coverage Analysis for clinical trials evaluating each protocol to determine the billing designation for all study-related procedures and services.
• Interpret clinical trial protocols informed consent documents budgets and related materials to identify billable services in accordance with CMS National Coverage Determinations (NCD) Local Coverage Determinations (LCD) and applicable laws and guidance.
• Develop and document billing grids aligned with MCA determinations to distinguish between routine costs billable to third-party payers and those covered by the study sponsor or grant.
• Collaborate with study teams principal investigators budget analysts and compliance personnel to ensure clarity consistency and accuracy of MCA results and associated billing plans.
• Support the activation process for oncology specialty and investigator-initiated trials by providing MCA deliverables within defined timelines.
• Maintain current knowledge of billing compliance requirements and research-related regulatory changes particularly related to Medicare rules and National Coverage Determination (NCD) 310.1.
• Participate in audits and monitoring activities related to billing compliance and coverage determinations.
• Assist with continuous process improvement initiatives to enhance the efficiency and quality of coverage analysis processes.
• Provide education and support to research staff on billing compliance and the implications of MCA outcomes.
• Assist with building reviewing & making changes to financial builds in the Clinical Trials Management System (CTMS).

Education and Experience:

• Bachelors degree in healthcare administration life sciences nursing finance or related field required.
• Experience performing Medicare Coverage Analysis in a healthcare or clinical research setting; experience with oncology trials strongly preferred.
• Experience with coverage analysis for investigator-initiated and specialty trials in an academic or integrated health system is highly desirable.
• Certification in Clinical Research Billing (e.g. ACRP SOCRA or CRB from the Society of Clinical Research Associates or a similar body) is a plus.

Knowledge and Skills:

• In-depth understanding of clinical research operations protocol design and billing compliance requirements.
• Proficiency in interpreting Medicare regulations NCD/LCD policies and research billing guidelines.
• Familiarity with clinical trial management systems (CTMS) electronic medical records (EMR) and billing systems.
• Strong analytical organizational and communication skills.
• Ability to work both independently and collaboratively in a fast-paced regulated environment.

Qualifications

Bachelors degree required.

Minimum of two years experience in clinical research coding or clinical trial billing preferred.

Sanford is an EEO/AA Employer M/F/Disability/Vet.

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