Site Budget Specialist I.

Psi; Bogotá; Remote; COP 27,900,000 - 50,220,000; Full time

Job summary

Psi in Colombia is seeking a coordinator to support clinical research startup activities from a home-based position.

You will negotiate site budgets, CTAs, and investigator grants, coordinating with PSI Legal and study teams to finalize site-specific documents and manage contract execution and filing.

Qualifications

• Fluency in Spanish and English, oral and written.
• Previous experience working with study startup operations.
• PC skills to work with MS Word, Excel and PowerPoint.
• Knowledge of legal documents related to clinical trial sites is a plus.
• Ability to plan and work in a dynamic team environment.

Responsibilities

• Review and negotiate site budgets.
• Facilitate review and negotiation of CTAs and investigator grants between PSI Legal, the project team, and the study site.
• Customize and prepare contractually binding site-specific documents with PSI Legal.
• Track CTA and investigator grant negotiation status in CTMS.
• Prepare executable contracts, including grants, and coordinate signature processes.
• File executed contracts in the Trial Master File and maintain local documentation.
• Liaise with project team, translation and legal on contracting and grant negotiation matters.
• Support Study Startup team activities as needed.

Skills

Fluency in Spanish and English

Communication and collaboration

Team-oriented planning

Education

College/University degree

Tools

MS Word

Excel

PowerPoint

Job description

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 Colombia.
Only CVs in English will be considered.

You will:

• 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

Qualifications

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

Additional Information

Our mission is to be the best CRO in the world as measured by our employees, clients, sites, and vendors. Our recruitment process is easy and straightforward, and we’ll be there with you every step of the way.