Job Description
Company Description
PSI is a leading Contract Research Organization with 30 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
Additional Information
Advance your career in clinical research, coordinating a variety of tasks and learning new things while growing with the company.
