Site Contract Specialist I

PSI CRO AG; São Paulo; Teletrabalho; BRL 25.000 - 40.000; Tempo integral

Resumo da oferta

A leading Contract Research Organization is looking for a Clinical Research Associate to join the LatAm team. In this full-time role, you will facilitate clinical trial agreements and support the study startup process. You will gain hands-on experience in a dynamic environment and develop your skills in clinical research while contributing to essential projects.

Qualificações

• Previous experience working with study startup operations is required.
• Fluency in Portuguese and English, oral and written.
• Knowledge of legal documents related to clinical trial sites is a plus.

Responsabilidades

• Review and negotiate site budgets.
• Facilitate review and negotiation of CTAs and grants.
• Support Study Startup team as needed.

Conhecimentos

Communication

Collaboration

Planning

Formação académica

College/University degree

Ferramentas

MS Word

Excel

PowerPoint

Descrição da oferta de emprego

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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 coordinate the signature process
• File executed contracts in the Trial Master File and maintain local documentation
• Liaise 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.

Seniority level

• Associate

Employment type

• Full-time

Job function

• Administrative

Industries

• Pharmaceutical Manufacturing