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 support critical studies in Argentina. In this senior position you will manage complex trial assignments, ensure patient safety, data quality, and mentor junior staff members.

Key responsibilities

• Oversee all aspects of site management, guaranteeing patient safety and high‑quality data with low query rates.
• Prepare sites for audits, support audit readiness, and follow up on corrective actions.
• Manage start‑up activities: feasibility assessments, EC/IRB submissions, regulatory document collection, informed‑consent preparation and translation, and investigator meetings.
• Assist with study‑budget negotiations and execution of investigator contracts as directed.
• Verify informed‑consent processes and monitor safety, protocol deviations, and pharmacovigilance issues.
• Conduct all types of site visits (pre‑study, initiation, routine monitoring, close‑out) in line with protocol, local laws, ICH‑GCP and SOPs.
• Perform monitoring oversight visits for junior CRA team members.
• Prepare accurate monitoring reports, documentation, and communication logs.
• Support patient recruitment, retention, and awareness strategies.
• Enter and track data in study‑specific tracking systems.

Required profile

• Senior‑level professional with broad experience handling complex clinical trials.
• Proven ability to manage independently sized or complex studies and support trial managers.
• Experience mentoring and training junior staff members.
• Strong knowledge of local regulations, ICH‑GCP, and SOP compliance.

Required skills

• ICH‑GCP compliance
• Clinical trial monitoring
• Regulatory document management
• EC/IRB submission processes
• Informed‑consent procedures
• Audit readiness and follow‑up
• Budget negotiation
• Investigator contract execution
• Data tracking system usage