Site Contract Specialist I

PSI CRO

3d • Remote

About The Position

Join our LatAm team to be the key support to clinical research projects as part of the start-up team. You will work in a dynamic multi-functional environment, gaining unique skills from various disciplines relevant to clinical research. Home-based position in Mexico. Only CVs in English will be considered.

Requirements

• College/University degree or an equivalent combination of education, training & experience
• Fluency in Spanish and English, oral and written
• 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

Nice To Haves

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

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
• Liase with the project team, translation, and legal departments on site contracting and grant negotiation matters
• Support the activities of Study Startup team if needed

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Associate degree