Clinical Trial Billing Analyst
16 days ago
Buffalo
Job Description Clinical Trials Medical Billing and Charge Specialist-REMOTE Hospital in NY is seeking a Clinical Trials Medical Billing and Charge Specialist. Looking for people who have done extensive “Coverage Analysis,” work as it relates to Clinical Trials. They are open to full time or part time contractors, the part time resource would need to be able to commit at least 20 hours per week. Job Description The Clinical Trials Medical Billing & Charge Monitoring Specialist is responsible for ensuring the accurate, timely, and compliant billing of clinical trial services, with a core focus on charge monitoring, designation of insurance responsibility, and sponsor invoicing. This position ensures financial integrity and regulatory compliance by validating charges against protocol calendars, coverage analyses, and other applicable documentation, while bifurcating which charges go to sponsors versus insurers. The successful candidate should possess a general working knowledge of clinical research workflows, Good Clinical Practice (GCP), and relevant federal regulations that support the integration of financial operations with research conduct and oversight. Key Responsibilities • Conduct thorough charge review (claim review) of clinical trial-related services across hospital and professional billing systems to ensure correct routing to insurance payers or study sponsors based on coverage analysis, protocol calendars, informed consent, and industry rules., • Validate charge level assignment of payment responsibility, using a working familiarity with ICD-10, CPT, and HCPCS codes while assigning modifiers (Q0, Q1), ensuring claims are in compliance with regulatory, institutional billing policies, and payer-specific rules., • Ensure documentation integrity by aligning charges with approved IRB protocols, study events, and subject enrollment status., • Collaborate with Clinical Trial Management System (CTMS) users (e.g., OnCore), study teams, and billing compliance staff to identify misrouted or non-compliant charges and correct them proactively., • Generate accurate and timely sponsor invoices for services covered under clinical trial agreements, including routine care, pass-through items, and administrative fees., • Track and reconcile sponsor receivables, assist with collections, and collaborate with Grants & Contracts, Research Finance, and Principal Investigators as needed., • Participate in internal reviews, external audits, and corrective action planning related to clinical research billing and sponsor financial reconciliation., • Document and continuously improve standard operating procedures (SOPs) for charge review, sponsor billing, and compliance workflows., • Serve as a resource and liaison between clinical research teams, finance, revenue cycle, and compliance stakeholders to ensure financial operations align with research best practices and policies., • Maintain awareness of and operate in accordance with Good Clinical Practice (GCP) guidelines, ICH E6 (R2) standards, and institutional research billing compliance requirements., • 2 years of relevant experience in clinical research billing, charge review, sponsor invoicing, or healthcare revenue cycle operations., • Comfort working with Charge Description Master (CDM) entries, ICD-10, CPT, HCPCS codes as components of billing requirements for clinical research encounters., • Familiarity with clinical trial workflows, including coverage analysis, IRB approval processes, informed consent documentation, protocol calendar management, and sponsor contracting., • Working knowledge of Good Clinical Practice (GCP), FDA regulations, OHRP guidelines, and HIPAA as they pertain to human subject research., • Understanding of common compliance guidelines in research billing, such the CMS Clinical Trial Policy (NCD 310.1), False Claims Act, Medicare Secondary Payer Rule., • Exposure to Clinical Trial Management Systems (CTMS) such as OnCore, Velos, Veeva, Huron Click, SignalPath, or others., • Experience with medical billing platforms and EHRs (e.g., Athena IDX, Sunrise Clinical Manger, Epic, Cerner)., • Excellent attention to detail, communication, and organizational skills. Preferred Skills • Bachelor’s degree in Health Information Management, Healthcare Administration, Clinical Research, Nursing, Compliance, or a related field. Experience beyond the 2-year minimum may be considered in lieu of a degree., • Professional certification such as Certified Professional Biller (CPB), Certified Professional Coder (CPC), Certified in Healthcare Research Compliance (CHRC), or similar., • Experience working within an academic medical center, cancer center, or NCI-designated research institution., • Familiarity with sponsor invoicing for industry-sponsored, federally funded, or cooperative group trials., • Working knowledge of research finance systems, sponsor portals, and contract lifecycle tools.
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