FSP Site Budget & Contracts Specialist

Fortrea•Durham, CA

2d•$80,000 - $89,000•Remote

About The Position

Fortrea is hiring a Site Budget & Contracts Specialist for its FSP team. This home-based position is available in the USA or Canada. The specialist prepares country site budgets and study financial appendices and assists with negotiating site agreement budgets and financial exhibits of varying complexity. The role coordinates clinical trial agreement (CTA) development, negotiation, execution, tracking, and audit readiness, working with study teams, sites, legal departments, and other stakeholders. It also includes researching medical procedure costs, maintaining contract templates and records, and negotiating Master Services Agreements with institutions.

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 and 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 and carry light to moderate loads, including luggage and a laptop, up to 15–20 lbs.
Regular and consistent attendance.
Varied hours may be required.

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, and ensure timely execution to meet study start-up timelines.
Liaise with legal departments to ensure CTA content changes are mutually agreeable and comply with the client’s legally approved standard agreement language.
Participate in study kick-off meetings to obtain information needed for effective CTA execution.
Assess proposed CTA language modifications; discuss noncompliant language with legal and work with legal departments, sites, contractors, or vendors to resolve issues.
Generate site budgets based on final approved country budgets, prepare them for distribution to sites, and follow up with investigators.
Research medical procedure costs using local or global databases to support accurate site-level budgets and cost calculations for new studies.
Manage CTAs and ensure agreement changes and related components are updated 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 locally 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 the communication and collaboration point person among clinical trial site personnel, client stakeholders, legal counsel, and the Manager of Insurance 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 have been conducted and ensure they are reviewed before renewal dates.