Clinical Research Associate (CRA) – Santiago, Chile

About the role

The Clinical Research Associate 2 (CRA 2) will monitor and manage clinical trial sites in Santiago, ensuring compliance with study protocols, regulatory requirements and international guidelines. You will support site initiation, recruitment, data quality and maintain clear communication with study teams and stakeholders.

Key responsibilities

• Conduct site monitoring visits (selection, initiation, monitoring, close‑out) in line with GCP and ICH standards.
• Collaborate with sites to develop and track subject recruitment plans.
• Provide protocol and study‑related training to assigned sites and maintain regular communication.
• Assess site practices for quality and regulatory compliance; escalate issues when needed.
• Track study progress, including regulatory submissions, enrollment, CRF completion and data query resolution.
• Verify that Investigator Site Files are maintained according to GCP/ICH and local regulations and are available for the Trial Master File.
• Document monitoring findings, visit reports and follow‑up actions.
• Assist with site financial processes such as invoice retrieval.

Required profile

• Bachelor’s degree in a scientific discipline or healthcare (preferred).
• Minimum 2 years of experience in clinical research monitoring.
• Advanced English proficiency.
• Strong analytical, organizational and communication abilities.
• Capacity to manage multiple sites and interact effectively with research teams and stakeholders.

Required skills

• Good Clinical Practice (GCP) knowledge.
• International Conference on Harmonization (ICH) guidelines familiarity.
• Clinical trial monitoring and site management.
• Regulatory document handling and compliance tracking.