Site Contract Specialist I

Psi CRO; Bogotá ciudad; On-site; COP 36,000,000 - 60,000,000; Full time

Benefits offered by this job

Remote work in Colombia

Job summary

INGEPSY is seeking a remote-based professional in Colombia to support clinical research projects as part of the LatAm start-up team. The role involves reviewing budgets, negotiating CTAs and investigator grants, and coordinating contract execution and filing. Fluency in Spanish and English is required.

The position offers exposure to multi-disciplinary processes in a dynamic team, with opportunities to interact with PSI Legal and study sites. English CVs only will be considered.

Qualifications

• College or university degree or an equivalent combination of education, training & experience.
• Fluency in Spanish and English, oral and written.
• Experience 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 a plus.
• Proficient with MS Word, Excel and PowerPoint.

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 site-specific documents in cooperation with PSI Legal.
• Track CTA and investigator grant negotiation status in the CTMS.
• Prepare executable contract versions including grants and coordinate signatures.
• File executed contracts in the Trial Master File and maintain local documentation.
• Coordinate with project team, translation and legal departments on site contracting and grant negotiations.
• Support Study Startup team activities if needed.

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.