Site Contract Specialist I

Summary

Join PSI's LatAm team as a key support for clinical research projects. Work in a dynamic, multi-functional environment, gaining unique clinical research skills. This home-based position in Brazil requires reviewing and negotiating site budgets and clinical trial agreements (CTAs). You will customize and prepare site-specific documents, track CTA and grant negotiation status, prepare contracts, and coordinate the signature process. Maintain local documentation and liaise with project teams and legal departments. Support the Study Startup team as needed. Only English CVs will be considered.

Requirements

• College/University degree or an equivalent combination of education, training & experience
• Previous experience working with study startup operations is required
• PC skills to be able to work with MS Word, Excel and PowerPoint
• Ability to plan and work in a dynamic team environment
• Communication and collaboration skills
• Fluency in Portuguese and English, oral and written

Responsibilities

• Review and negotiate site budgets
• Facilitate the review and negotiation of clinical trial agreements (CTAs) and investigator grants between PSI Legal, the project team, and the study site
• Customize and prepare contractually binding site-specific documents in cooperation with PSI Legal
• Track CTA and investigator grant negotiation status in the Clinical Trial Management System (CTMS)
• Prepare the executable version of the contract, including grants, and coordinates the signature process
• File executed contracts in the Trial Master File and maintains local documentation
• Liaise with the project team, translation, and legal departments on site contracting and grant negotiation matters
• Support the activities of Study Startup team if needed

Preferred Qualifications

• Experience with finance and negotiation is desirable
• Knowledge and experience with legal documents related to clinical trial sites would be considered a plus