Site Budgeting and Contracting Specialist - FSP

Fortrea•Durham, CA

4d•$80,000 - $89,000•Remote

About The Position

Fortrea's FSP team is hiring a Budget Builder & Site Contract Specialist. This role is home-based in the USA or Canada. The specialist 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, as part of a global team. The role requires a solid understanding of standard contract language to enable decision-making regarding CTA sections when modifications are proposed by external parties, and to resolve issues in conjunction with legal departments, sites, contractors, or vendors.

Requirements

2+ years of budget/contract negotiation experience at CRO level
Direct site facing experience
Experience building global budget templates
Bachelors’ degree or an equivalent scientific or commercial Higher Vocational education
Experience in the healthcare field, pharmaceutical industry or clinical research preferred
Must be site facing

Responsibilities

Develop Clinical Trial Agreements (CTAs) utilizing standard templates and information from Contract Information Sheets, ensuring timely execution to meet study start-up timelines.
Liaise with legal departments to ensure content changes to CTAs are mutually agreeable and in accordance with the 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 budgets 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 the client's legal standards and 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, coordinating timely updates with respect to CTAs, ensuring accuracy, and reconciling 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 annual audits.
Serve as the point person for communication and collaboration among clinical trial site personnel, the client's Head, 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 renewal dates.
Support the building of country study site budget templates, parameters, and payment terms to ensure timely setup of individual site budgets.
Manage and execute assigned study site budget maintenance activities throughout the life of the study.
Negotiate directly with globally assigned sites master clinical trial agreements rate cards.
Partner with the site payment department to ensure site budget and payment terms compatibility with payment systems and EDC requirements.
Partner with internal Study Startup team, Clinical Operations teams, and TAU partners to improve overall SB&C metrics and implement processes.
Ensure standards are applied to SB&C processes across projects and portfolios, and support continuous improvement activities while developing TA-aligned strategies.
Leverage leading industry tools and data sources to provide budget and payment terms feedback aligned with parameters and fair market value guidance.
Promptly recognize and improve potential delays and escalate non-performance.