FSP Site Budget & Contracts Specialist

Fortrea•Durham, NC

1d•Remote

About The Position

Fortrea's FSP team is hiring Site Budget & Contracts Specialists to work from home in the USA or Canada. As part of a global team, the specialist prepares country site budgets and study financial appendices and assists with negotiating site agreement budgets and financial exhibits of a certain complexity. The role develops and manages Clinical Trial Agreements (CTAs), supports timely study start-up, coordinates with legal departments and clinical trial site personnel, maintains contract records, and ensures compliance with client legal standards and global SOPs. The specialist also negotiates Master Services Agreements with institutions and helps maintain documentation for audits. Work is performed in an office environment with exposure to electrical office equipment, and the role involves frequent travel to client and site locations, with occasional domestic and international travel. Varied hours may be required. The position requires regular and consistent attendance and the ability to sit for extended periods, use computer software, operate a vehicle safely, perform repetitive hand movements, and occasionally crouch or stoop, frequently bend and twist the upper body and neck, and lift or carry objects weighing up to 15–20 pounds.

Requirements

Bachelor’s degree or equivalent scientific or commercial Higher Vocational education.
Ability to sit for extended periods and operate a vehicle safely.
Ability to perform repetitive hand movements, including fast, simple, repeated movements of the fingers, hands, and wrists.
Ability to crouch and stoop occasionally and bend and twist the upper body and neck frequently.
Ability to access and use a variety of in-house and off-the-shelf computer software.
Ability to lift or carry objects, including luggage and a laptop computer, weighing up to 15–20 pounds.
Regular and consistent attendance.

Nice To Haves

Experience in healthcare, the pharmaceutical industry, or clinical research.

Responsibilities

Develop Clinical Trial Agreements (CTAs) using standard templates and information from Contract Information Sheets.
Ensure CTAs are executed in a timely manner to meet expected study start-up timelines.
Coordinate with legal departments to ensure CTA changes are mutually agreeable and comply with clients’ legally approved standard agreement language.
Participate in study kick-off meetings to obtain information needed for effective CTA execution.
Assess proposed CTA language modifications and work with legal departments, sites, contractors, or vendors to resolve noncompliant language.
Generate site budgets based on final approved country budgets, distribute them to sites, and follow up with investigators.
Research medical procedure costs using local or global databases to support accurate site-level budgets and procedure cost calculations for new studies.
Manage CTAs and update agreements and related components in accordance with client legal standards and global SOPs.
Coordinate annual reviews of templates with the Legal department and Local Head of Monitoring and Site Management.
Manage the contract tracking database, coordinate timely CTA updates, ensure information accuracy, and reconcile discrepancies between documents and the database.
Post fully executed contracts in eFiliA and on the Clinical Operations secure drive.
Process study internal approval forms and other documents required for compliance with the Internal Signatory Process and annual audits.
Serve as a communication and collaboration point person among clinical trial site personnel, client representatives, Legal Counsel, and the Manager of Insurance throughout contract negotiations.
Prepare for internal audits by maintaining complete and accurate documentation of each site contract negotiation.
Negotiate Master Services Agreements (MSAs) with institutions where clinical trials have been conducted and ensure they are reviewed before renewal dates.