Clinical Research Coverage Analyst

Who is Saint Louis University? Founded in 1818, Saint Louis University is one of the nation's oldest and most prestigious Catholic universities. SLU, which also has a campus in Madrid, Spain, is recognized for world-class academics, life-changing research, compassionate health care, and a strong commitment to faith and service.

The Clinical Research Coverage Analyst plays a critical role in supporting clinical research operations, study activation, and compliant research billing practices within the School of Medicine. This position serves as the institutional subject matter expert for Medicare Coverage Analysis (MCA), qualifying clinical trial (QCT/QTC) determinations, clinical trial billing compliance, and research-related reimbursement requirements.

Working collaboratively with investigators, study teams, research administrators, sponsors, and healthcare system partners, the Clinical Research Coverage Analyst performs comprehensive coverage analyses to determine appropriate billing pathways for research-related services and procedures. The analyst helps ensure compliance with federal regulations, CMS guidance, institutional policies, and payer requirements while supporting efficient study start-up and activation processes.

This role is ideal for individuals with experience in clinical research, healthcare reimbursement, research administration, clinical operations, revenue cycle management, regulatory compliance, or clinical trial management.

Primary Responsibilities

Clinical Trial Coverage Analysis & Billing Compliance

• Review clinical trial protocols, informed consent documents, budgets, contracts, and related study documents to determine Qualifying Clinical Trial (QCT/QTC) status in accordance with CMS and applicable regulatory guidance.

• Conduct detailed Medicare Coverage Analyses (MCAs) to identify routine care costs, research-related costs, and sponsor-funded items and services.

• Determine appropriate billing designations and payment responsibilities for study-related procedures, services, tests, and visits.

• Serve as a subject matter expert on National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), Medicare Clinical Trial Policy, and research billing compliance requirements.

• Collaborate with investigators, clinical research coordinators, study teams, sponsors, and institutional stakeholders to resolve coverage analysis and billing-related questions.

• Review study documentation for consistency and alignment across protocols, consent forms, budgets, contracts, and billing plans.

• Maintain accurate and compliant study records and documentation supporting coverage determinations.

Study Activation & Operational Support

• Partner with affiliated healthcare system teams to support research study activation and implementation within electronic medical record (EMR) systems.

• Coordinate submission of study build requests and related documentation.

• Monitor study build status, maintain tracking systems, and facilitate corrections or updates as needed.

• Contribute to process improvement initiatives that enhance study activation efficiency and research operations.

Education & Training

• Develop and deliver education, training, and guidance related to clinical trial billing compliance, Medicare Coverage Analysis, and research operations.

• Create standardized tools, resources, and best-practice guidelines to support the research community.

• Support onboarding and continuing education efforts for clinical research professionals, including research coordinators and study teams.

• Serve as a trusted resource to faculty, investigators, and staff regarding clinical research billing and compliance requirements.

Collaboration & Program Support

• Participate in clinical research governance, compliance, and operational meetings.

• Assist with initiatives that strengthen research infrastructure, regulatory compliance, and operational effectiveness.

• Support organizational goals related to research quality, compliance, and continuous improvement.

• Perform other duties as assigned.

Knowledge, Skills, and Abilities

• Knowledge of clinical research regulations, guidelines, and good clinical practice (GCP) principles.

• Understanding of Medicare Coverage Analysis, clinical trial billing compliance, healthcare reimbursement, or revenue cycle processes.

• Knowledge of clinical trial operations, study start-up, and research administration practices.

• Strong analytical and critical-thinking skills with the ability to interpret complex clinical, regulatory, and billing information.

• Excellent organizational skills with strong attention to detail and accuracy.

• Ability to assess and resolve complex issues using sound judgment and independent decision-making.

• Strong verbal and written communication skills with the ability to explain technical concepts to diverse audiences.

• Experience developing and delivering training, presentations, or educational materials.

• Ability to manage multiple priorities and meet deadlines in a dynamic environment.

• Proficiency with Microsoft Office applications and other business software systems.

• Ability to maintain confidentiality and handle sensitive information appropriately.

Minimum Qualifications

• Associate degree in healthcare administration, clinical research, business, life sciences, nursing, public health, finance, revenue cycle, or a related field.

• Five (5) years of professional experience in clinical research, healthcare reimbursement, revenue cycle management, research administration, clinical trial operations, research billing compliance, healthcare compliance, or a related analytical healthcare field.

• Experience reviewing and interpreting complex clinical, regulatory, financial, billing, or operational documents and making compliance-based or financial determinations.

• Experience working with multiple stakeholders to resolve operational, compliance, billing, or research-related issues.

• Experience interpreting and applying regulatory, payer, clinical research, or billing requirements to operational workflows is required.

• Equivalent combinations of education and directly related experience may be considered.

Equivalent combinations of education and applicable experience may be considered.

Preferred Qualifications

• Bachelor's degree in healthcare administration, public health, life sciences, business administration, nursing, or related field.

• Experience conducting Medicare Coverage Analyses (MCA) or Clinical Trial Coverage Analyses.

• Ability to interpret complex clinical trial protocols, schedules of assessments, and clinical study documentation.

• Experience with clinical trial billing compliance and CMS regulations.

• Experience in an academic medical center, healthcare system, research institution, or clinical research organization (CRO).

• Knowledge of clinical trial budgeting, contracts, and study start-up processes.

• Experience working with electronic medical record (EMR) systems.

• CPT, ICD, HCPCS, coding, billing, or revenue cycle experience.

• Clinical Research Professional (CCRP), Certified Clinical Research Coordinator (CCRC), or similar certification.

• Experience training, mentoring, or educating clinical research staff.

Function

Clinical Research

Scheduled Weekly Hours:

40

Saint Louis University is an equal opportunity/affirmative action employer. All qualified candidates will receive consideration for the position applied for without regard to race, color, religion, sex, age, national origin, disability, marital status, sexual orientation, military/veteran status, gender identity, or other non-merit factors. If accommodations are needed for completing the application and/or with the interviewing process, please contact Human Resources at 314-977-5847.