Clinical Trials Budget & Contracts Specialist
Budget & Contract Preparation
Aid in the preparation and review of live budgets and Clinical Trial Agreements (CTAs) with Sponsors, CROs, and vendors.
Support the facilitation of Outsourced Service Agreements, ensuring contract compliance.
Maintain proactive communication with sponsors through the execution of CTAs, ensuring all data is accurate and tracked within internal systems.
Assist in reviewing protocol amendments to determine necessary budget adjustments, ensuring all changes align with company requirements.
Help facilitate budget and contract amendments, ensuring the accounting department is updated so changes are reflected in financial systems.
Documentation & Compliance
Maintain meticulous records of all budget-related correspondence, stipends, and site-specific documents.
Ensure all financial activities comply with current protocols, SOPs, GCP, IRB, and FDA guidelines.
Knowledge, Skills, & Abilities
Financial Literacy: Ability and willingness to develop an understanding of clinical trial billing, fair market value (FMV), and revenue cycles.
Negotiation & Review: Ability to review and support the negotiation of financial terms with external sponsors and CROs.
Analytical Rigor: High level of attention to detail for reviewing complex legal and financial documents.
Communication: Ability to translate complex budget data into actionable information for management and Accounting teams.
Systems Proficiency: Experience with CTMS (Clinical Trial Management Systems) or advanced Excel functions, preferred.
Qualifications
Experience: 2+ years of experience in clinical trial budget development, contract administration, or healthcare financial analysis.
Education: Bachelor’s degree in Finance, Accounting, Healthcare Administration, or a related field.