Site Budget & Contracts Specialist, FSP

Fortrea•Durham, NC

1d•$80,000 - $89,000•Remote

About The Position

Fortrea's FSP team is hiring Site Budget & Contracts Specialists! This is a home-based role in the USA or Canada. The successful candidate will be responsible for preparing country site budgets and study financial appendices, and assisting with the negotiation of site agreement budgets and financial exhibits of a certain complexity. This role requires a solid understanding of standard contract language to enable decision-making regarding CTA sections when modifications are proposed by external parties. If language is not compliant, the specialist will discuss issues with legal and work with the legal department, sites, contractors, or vendors to resolve them. The role also involves managing CTAs, ensuring all changes to agreements are updated according to client’s legal standards and Global SOPs, and managing the contract tracking database for accuracy and reconciliation. The specialist will also be responsible for posting fully executed contracts and processing internal approval forms to ensure compliance with the Internal Signatory Process and for annual audits. Excellent communication and collaboration are expected as the point person among clinical trial site personnel, client's Head of Clinical Operations, Legal Counsel, and Manager of Insurance throughout the contract negotiation process. The role also includes preparing for internal audits by maintaining a complete and accurate paper trail for each site contract negotiation and negotiating Master Services Agreements (MSAs) with institutions.

Requirements

2+ years of budget/contract negotiation experience at CRO level with direct site facing experience.
Must have a Bachelors’ degree or an equivalent scientific or commercial Higher Vocational education.
Experience in the healthcare field, pharmaceutical industry or clinical research preferred.

Responsibilities

Prepare country site budgets and study financial appendices.
Assist with the negotiation of site agreement budgets and financial exhibits of a certain complexity.
Develop Clinical Trial Agreements (CTAs) utilizing standard templates and information from Contract Information Sheets.
Ensure CTAs are executed in a timely manner to meet expected timelines for study start-up.
Liaise with legal departments to ensure content changes to CTAs 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.
Generate site budgets based on final approved country budget in preparation for distribution to sites and follow up with investigators.
Research medical procedure costs using local or global databases to provide accurate data for site level budget development.
Manage CTAs, ensuring all changes to agreements and corresponding components are updated according to client’s legal standards and client Global SOPs.
Ensure annual review of all templates with the Legal department and Local Head of Monitoring and Site Management.
Manage the contract tracking database, including coordination of timely updates with respect to CTA.
Ensure accuracy of information and reconcile discrepancies between documents and the database.
Post fully executed contracts in eFiliA and locally on the Clinical Operations secure drive.
Process internal approval forms and other documents for each study to ensure compliance with the Internal Signatory Process and for annual audits.
Ensure excellent communication and collaboration as the point person among clinical trial site personnel, client’s Head of Clinical Operations, Legal Counsel, and Manager, Insurance, throughout the contract negotiation process.
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 have been conducted and ensure they are reviewed prior to their renewal dates.