Senior Clinical Research Associate – Argentina

About the role

We are expanding our clinical research capabilities across Latin America and are looking for a Senior Clinical Research Associate to lead complex studies in Argentina. You will oversee site start‑up, monitoring, and ongoing management to ensure patient safety and high‑quality data.

Key responsibilities

• Independently manage all aspects of site start‑up, including feasibility, EC/IRB submissions, regulatory document review, and investigator contract negotiation.
• Conduct pre‑study, initiation, routine monitoring, and close‑out visits in compliance with protocol, local laws, ICH‑GCP and company SOPs.
• Maintain trial management tools, status reports, and documentation such as confirmation letters and monitoring reports.
• Support recruitment, retention, and patient awareness strategies.
• Provide audit readiness guidance and assist with audit preparation and follow‑up actions.
• Mentor junior CRA staff and perform monitoring oversight visits.

Required profile

• Extensive experience managing complex clinical trials in a senior capacity.
• Proven ability to work independently and coordinate with Clinical Trial Managers or Project Managers.
• Strong understanding of regulatory requirements and patient safety considerations.
• Excellent organizational and communication skills, with a focus on quality and compliance.

Required skills

• ICH‑GCP compliance
• Clinical trial site monitoring
• Regulatory document management
• Site start‑up and feasibility assessment
• Budget negotiation and investigator contract management
• Pharmacovigilance awareness

What we offer

• Opportunity to work on high‑impact studies across Latin America.
• Collaborative environment with professional development and mentorship.