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Senior Clinical Trial Finance Specialist
POSITION SUMMARY:
The Senior Clinical Trial Finance Specialist supports the end-to-end financial management of sponsored clinical trials across the CVRS Clinical Research Network, with responsibility for both pre-award and post-award financial activities. This position independently manages the financial activities for an assigned portfolio of studies, including protocol and sponsor budget review, study budget development and negotiation, financial setup in REALTIME CTMS, monthly billing, billing quality control, coordination of invoiceable items, payment reconciliation, and financial closeout. The Senior Clinical Trial Finance Specialist reports to the Finance Manager and collaborates with research operations, contracting, research sites, participating practices, and sponsor/CRO finance representatives to ensure that study financial terms are accurately implemented and that earned research revenue is timely and appropriately captured.
ESSENTIAL DUTIES AND RESPONSIBILITIES (include, but are not limited to, the following):
Review clinical trial protocols, schedules of events, sponsor budgets, and supporting study documents to identify study-specific financial requirements and costs.
Develop comprehensive site budgets based on protocol-required visits, procedures, staffing, administrative requirements, and operational costs.
Independently negotiate clinical trial budgets with sponsors and CROs within established organizational parameters and maintain documentation of negotiations and final financial terms.
Identify costs not adequately represented in sponsor-provided budgets, including startup activities, administrative fees, screen failures, unscheduled visits, pharmacy and laboratory activities, annual fees, closeout costs, record retention, pass-through expenses, and other study-specific requirements.
Partner with research operations and participating practices to validate protocol requirements, resource needs, and associated costs and ensure negotiated budgets appropriately reflect study operations.
Translate executed clinical trial budgets and payment terms into accurate financial configurations within REALTIME CTMS, including visit budgets, procedures, milestones, invoiceable items, fees, pass-through expenses, and payment schedules.
Perform quality control of study financial setup against the final executed clinical trial agreement and budget prior to activation and maintain financial configurations as amendments or budget changes occur.
Complete monthly clinical trial billing activities for an assigned portfolio of studies and review participant and study activity to identify all billable events.
Coordinate and prepare invoices for contractually invoiceable items, including startup fees, milestones, screen failures, unscheduled visits, procedures, pass-through expenses, annual fees, pharmacy and laboratory costs, closeout fees, and other applicable items.
Maintain tracking of submitted and outstanding invoiceable items and work with research teams to obtain documentation necessary to support timely and accurate billing.
Perform detailed quality control of clinical trial billing prior to invoice submission by comparing billing activity against REALTIME, executed study budgets, payment terms, participant activity, and supporting documentation.
Identify and resolve missed charges, duplicate charges, incorrect rates, or other billing discrepancies and confirm that invoiceable items are billed in accordance with contractual terms.
Review sponsor and CRO payments against expected study revenue and submitted invoices and reconcile payments to participant visits, milestones, invoiceable items, and other study activity.
Identify, research, and support resolution of missing, incomplete, delayed, or incorrectly allocated payments with sponsor/CRO finance contacts and internal stakeholders.
Maintain accurate financial records for assigned studies and support reporting of expected revenue, invoiced amounts, payments received, outstanding invoiceable items, receivables, and unresolved financial discrepancies.
Support monthly and quarterly research financial reconciliation and identify potential revenue leakage to ensure earned research revenue is appropriately captured.
Complete comprehensive financial reconciliation at study closeout, confirming that all visits, procedures, milestones, fees, invoiceable activities, invoices, and payments have been appropriately captured and resolved.
Serve as a knowledgeable resource for clinical trial budget and billing questions and support consistent clinical trial finance processes and workflow improvements across the research network.
JOB REQUIREMENTS AND QUALIFICATIONS:
Required:
Bachelor's degree in finance, accounting, business, healthcare administration, clinical research, or a related field, or equivalent relevant experience.
3+ years of experience in clinical trial finance, clinical research budgeting, research administration, or a closely related function.
Experience with post-award clinical trial billing, invoicing, or financial reconciliation.
Ability to interpret clinical trial protocols, schedules of events, budgets, and financial terms.
Strong analytical, organizational, and reconciliation skills with exceptional attention to detail.
Strong Excel skills and comfort working with financial data.
Ability to independently manage multiple studies, deadlines, and financial workstreams.
Strong written and verbal communication skills.
Preferred:
Experience managing both pre-award and post-award clinical trial financial activities.
Experience with REALTIME CTMS or another clinical trial management system.
Experience with sponsor/CRO invoicing and payment portals.
Experience working within a multi-site clinical research network, site organization, health system, or similar research environment.
Familiarity with Medicare Coverage Analysis and clinical trial billing compliance.
FLSA Classification Rationale:
This position is classified as exempt because the Senior Clinical Trial Finance Specialist performs specialized clinical trial financial work requiring independent judgment and discretion, including development and negotiation of study budgets, interpretation and implementation of contractual financial terms, billing quality control, financial reconciliation, and resolution of complex study-level financial discrepancies, consistent with the administrative exemption under FLSA.
PHYSICAL REQUIREMENTS:
Ability to perform prolonged computer-based work and review detailed clinical trial budgets, invoices, payment documentation, and financial reports.
Ability to communicate effectively through virtual meetings, telephone, and electronic systems and to travel occasionally as business needs require.
DISCLAIMER:
The above job description has been written to indicate the general nature and level of work performed by employees within this classification. It is not written to be inclusive of all duties, responsibilities, and qualifications required of employees assigned to this job.
