Clinical Research Associate (Level II) – Clinical Monitoring

About the role

Join a global team that supports leading pharmaceutical and biotech companies across more than 100 countries. As a Clinical Research Associate (Level II) you will coordinate and execute all aspects of clinical site monitoring, ensuring trials are conducted according to protocol, ICH‑GCP, and regulatory standards.

Key responsibilities

• Perform risk‑based monitoring visits (remote or on‑site) to assess protocol compliance and data accuracy.
• Apply root cause analysis and corrective/preventive actions to resolve site process failures.
• Conduct source data review (SDR), source data verification (SDV), and case report form (CRF) review.
• Assess investigational product inventory and maintain related documentation.
• Document observations in reports and letters, following approved business writing standards.
• Escalate deficiencies to clinical management and follow issues through to resolution.
• Maintain regular contact with sites to ensure ongoing compliance and timely data capture.
• Participate in investigator payment, meetings, and site initiation/close‑out activities.

Required profile

• Experience in clinical monitoring or a similar role within pharmaceutical/biotech trials.
• Strong knowledge of ICH‑GCP guidelines, regulatory requirements, and SOPs.
• Ability to conduct both remote and on‑site monitoring activities.
• Analytical mindset with problem‑solving and root cause analysis capabilities.

Required skills

• Risk‑based monitoring
• Root cause analysis
• Source data review (SDR) and verification (SDV)
• Case report form (CRF) review
• Investigational product inventory management
• ICH‑GCP compliance

What we offer

• Opportunity to work on a diverse portfolio of global clinical trials.
• Collaboration with leading pharmaceutical and biotech sponsors.
• Professional development in clinical research and monitoring.