Fortrea's FSP team is hiring Site Budget & Contracts Specialists!
Home Based in USA.
Must have 2+ years of budget / contract negotiation experience at CRO level with direct site facing experience.
As part of a global team, you will be responsible for preparing country site budgets and study financial appendices, assisting with the negotiation of site agreement budgets and financial exhibits of a certain complexity.
Responsibilities include :
- Develop Clinical Trial Agreements (CTAs) utilizing standard templates and information from Contract Information Sheets. Ensure CTAs are executed in a timely manner to meet study start-up timelines. Liaise with legal departments to ensure content changes are mutually agreeable and in accordance with client's legally approved standard agreement language. Participate in Study kick-off meetings to obtain necessary information for effective CTA execution.
- Understand standard contract language to make decisions on CTA sections when language modifications are proposed. Discuss issues with legal and work with sites, contractors, or vendors to resolve non-compliance issues.
- Generate site budgets based on final approved country budgets, research medical procedure costs using local or global databases to provide accurate data for developing site-level budgets for new studies.
- Manage CTAs ensuring all changes are updated according to client's legal standards and SOPs.
- Ensure annual review of all templates with the Legal department and Local Head of Monitoring and Site Management.
- Manage the contract tracking database, ensure timely updates, accuracy, and reconcile discrepancies. Post fully executed contracts in eFiliA and locally on the Clinical Operations secure drive.
- Process internal approval forms and other documents required for compliance with the Internal Signatory Process and for audits.
- Maintain excellent communication and collaboration among clinical trial site personnel, client's Head, Clinical Operations, Legal Counsel, and others during contract negotiations.
- Prepare for internal audits by maintaining a complete and accurate paper trail for each site contract negotiation.
- Negotiate Master Services Agreements (MSAs) with institutions where clinical trials are conducted and review them prior to renewal dates.
Education : Must have a Bachelor's degree or equivalent scientific or commercial Higher Vocational education.
Experience : Experience in healthcare, pharmaceutical industry, or clinical research preferred.
Pay Range : $80,000 - $89,000 USD
Benefits : Comprehensive benefits including Medical, Dental, Vision, Life, STD / LTD, 401(K), ESPP, Paid time off, Flexible time off, and Company bonus where applicable. Applications are accepted on an ongoing basis. Learn more about our EEO & Accommodations request here.
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