Offer summary

Qualifications:

College/University degree or equivalent education and experience, Previous experience in study startup operations, Desirable experience in finance and negotiation, Fluency in Portuguese and English, both oral and written..

Key responsibilities:

Review and negotiate site budgets

Facilitate the negotiation of clinical trial agreements and investigator grants

Track negotiation status in the Clinical Trial Management System

Prepare and file executed contracts in the Trial Master File.

Job description

Company Description

PSI is a leading Contract Research Organization with more than 27 years in the industry offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications.

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 Brazil.
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
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
Fluency in Portuguese and English, oral and written