FSP Site Budget & Contracts Specialist

Overview

The organization is hiring Site Budget & Contracts Specialists to support the FSP team.

Location

Home based in USA or Canada.

Responsibilities

• Develop Clinical Trial Agreements (CTAs) using standard templates and information from Contract Information Sheets, ensuring execution timelines support expected study start-up schedules.
• Liaise with legal departments to ensure content changes to CTAs are mutually agreeable and aligned with client-approved standard agreement language.
• Participate in Study kick-off meetings to obtain information required for effective CTA execution.
• Apply a solid understanding of standard contract language to support decision-making on CTA sections when external contract parties propose language modifications.
• If proposed language is not compliant, discuss issues with legal and work with the legal department, sites, contractors, or vendors to resolve them.
• 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, enabling Country Lead Monitors/Study Managers to calculate the latest average costs on procedures for new studies.
• Manage CTAs to ensure all agreement changes and corresponding components are updated according to client legal standards and client Global SOPs.
• Coordinate annual review of all templates with the Legal department and Local Head of Monitoring and Site Management.
• Manage a contract tracking database, coordinating timely updates related to CTAs.
  • Ensure accuracy of information.
  • Reconcile discrepancies between documents and the database.
  • Post fully executed contracts in eFiliA and locally on the Clinical Operations secure drive.
• Complete, per study, internal approval forms and other documents required for compliance with the Internal Signatory Process and for annual audits.
• Serve as a point person and ensure excellent communication and collaboration among clinical trial site personnel (Investigator, Study Coordinator, Institution’s Legal Counsel), client leadership (Head of Clinical Operations, Legal Counsel, and Manager), and Insurance during the contract negotiation process.
• Support 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.

Education

• Bachelor’s degree or an equivalent scientific or commercial Higher Vocational education.

Requirements

• Experience in the healthcare field, pharmaceutical industry, or clinical research is preferred.

Compensation & Benefits

• Pay Range: $80,000–$89,000 USD (this range does not apply to candidates residing in Canada).
• Benefits: Job offers are based on skills and relevant experience, applicable degrees/certifications, internal equity, and market data.
• Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including:
  • Medical, Dental, Vision
  • Life
  • STD/LTD
  • 401(K)
  • ESPP
  • Paid time off (PTO) or Flexible time off (FTO)
  • Company bonus where applicable

Work Environment & Physical Requirements

• Office environment with exposure to electrical office equipment.
• Frequent travel to client/site locations, with occasional domestic and international travel.
• Ability to sit for extended periods and operate a vehicle safely.
• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
• Occasional crouching and stooping; frequent bending and twisting of upper body and neck.
• Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
• Light to moderate lifting and carrying (or otherwise moving) objects including luggage and a laptop computer with a maximum lift of 15–20 lbs.
• Regular and consistent attendance.
• Varied hours may be required.

Additional Information

Applications will be accepted on an ongoing basis.