NYU is seeking an experienced Clinical Research Budget Analyst to support the development, review, and negotiation of clinical trial budgets. This individual will serve as a key point of contact for investigators and study teams, managing the budgeting process from initial protocol review through final negotiation and study activation.
The ideal candidate has prior experience independently developing and negotiating clinical research budgets, understands research billing compliance, and is comfortable reviewing clinical trial protocols to identify procedures, costs, personnel effort, and other study-related expenses.
Key Responsibilities
- Review clinical research protocols and assess all procedures, personnel, administrative requirements, and other study-related costs.
- Develop comprehensive internal clinical trial budgets within the Clinical Research Management System (CRMS).
- Determine appropriate costs, time and effort fees, inflation, margins, and other applicable expenses to ensure studies are appropriately funded.
- Perform financial analysis to determine study costs and break-even points.
- Compare internal budgets against sponsor proposals and independently negotiate clinical trial budgets with sponsors through completion.
- Ensure all research procedures, subject costs, personnel expenses, administrative fees, and reimbursable items are appropriately captured.
- Review protocol amendments and determine their impact on existing budgets and contracts; revise and renegotiate budgets as needed.
- Partner with investigators, study teams, Research Finance, Sponsored Projects, and other internal stakeholders throughout the pre-award budgeting process.
- Ensure finalized sponsor invoicing terms, visit descriptions, payments, optional procedures, subject stipends, travel, and other reimbursable items are accurately entered into the CRMS.
- Collaborate with internal teams to ensure negotiated budgets and billing terms align with executed clinical trial agreements.
- Support study activation once budget, contract, and central office requirements are complete.
- Participate in process improvement initiatives related to clinical research budgeting and financial operations.
- Collaborate with Epic and IT teams as the organization develops and transitions to an updated clinical research management system.
Required Qualifications
- Bachelor’s degree in Accounting, Finance, Healthcare, or a related field.
- 2+ years of experience developing and negotiating budgets, with clinical research budgeting experience strongly preferred.
- Knowledge of pre- and post-award research or grant management.
- Hands-on experience with clinical trial budget development, sponsor negotiation, and protocol review.
- Experience with research billing compliance in a clinical research or healthcare setting.
- Ability to read and interpret clinical research protocols and translate study requirements into a comprehensive budget.
- Working knowledge of National Coverage Determinations (NCDs/NCCDs), CMS Clinical Research Policy, and routine cost coverage.
- Strong analytical, mathematical, and financial skills with close attention to detail.
- Advanced proficiency with Microsoft Excel.
- Strong written and verbal communication skills with the ability to work directly with investigators, study teams, sponsors, and internal stakeholders.
Preferred Qualifications
- Experience within an academic medical center, hospital, pharmacy, or similar clinical research environment.
- Previous experience working independently in a clinical research budget analyst or similar capacity.
- Experience with oncology clinical trials.
- Experience with clinical research management systems (CRMS) and/or Epic.
- Experience supporting process improvement or system implementation initiatives.