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 be responsible for end‑to‑end site management, ensuring patient safety, data quality, and regulatory compliance.

Key responsibilities

• Oversee all aspects of study site management, from start‑up to close‑out, ensuring low query rates and high data integrity.
• Prepare and submit EC/IRB documentation, regulatory files, and informed consent materials, including translations.
• Conduct pre‑study, initiation, routine monitoring, and close‑out visits in line with ICH‑GCP, local laws, and company SOPs.
• Support audit readiness, guide sites through audit preparation, and manage follow‑up actions.
• Assist with budget negotiations and investigator contract execution as directed.
• Mentor junior CRA staff and provide oversight visits for team members.

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 patient safety, data quality, and regulatory compliance.
• Excellent communication skills for interacting with investigators, IRBs, and internal teams.

Required skills

• ICH‑GCP knowledge
• Clinical trial management systems
• Regulatory submission processes (EC/IRB)
• Site monitoring and audit preparation
• Pharmacovigilance awareness
• Data tracking and reporting tools

What we offer

• Opportunity to lead high‑impact studies in a growing Latin American market.
• Collaborative environment with experienced clinical research professionals.
• Professional development and mentorship opportunities.