Clinical Research Associate – Site Monitoring

About the role

The Clinical Research Associate (CRA) will perform site monitoring and management activities to ensure that clinical studies are conducted according to protocol, regulatory requirements, and sponsor expectations. Based in Mexico City, the CRA will travel to study sites, support subject recruitment, and maintain high‑quality data collection.

Key responsibilities

• Conduct site monitoring visits (selection, initiation, routine monitoring, and close‑out) in line with Good Clinical Practice.
• Collaborate with sites to develop and track subject recruitment plans.
• Provide protocol and study‑specific training to site staff and maintain regular communication.
• Assess site compliance with protocol, regulations, and GCP; escalate quality issues when needed.
• Track regulatory submissions, enrollment, CRF completion, and data query resolution.
• Ensure site documents are filed correctly in the Trial Master File and Investigator Site File.
• Prepare monitoring visit reports, follow‑up letters, and other required documentation.
• Support site financial management and invoice processing as required.

Required profile

• Bachelor’s degree in a scientific discipline or health‑care field (preferred).
• Minimum 2 years of on‑site monitoring experience.
• Willingness to travel for onsite monitoring.
• Residence in Mexico City.
• Strong knowledge of GCP, ICH guidelines, and clinical research regulatory requirements.
• Excellent written and verbal English communication skills.
• Strong organizational, problem‑solving, and time‑management abilities.

Required skills

• Microsoft Word
• Microsoft Excel
• Microsoft PowerPoint
• Good Clinical Practice (GCP) knowledge
• International Conference on Harmonisation (ICH) guidelines
• Clinical research regulatory requirements