Clinical Research Associate II

About the role

Join a global team that supports leading pharmaceutical and biotech companies in delivering clinical trials across more than 100 countries. As a Clinical Research Associate II you will coordinate monitoring activities, ensure protocol compliance, and safeguard data integrity for assigned investigational sites.

Key responsibilities

• Conduct remote and on‑site monitoring visits using a risk‑based approach.
• Apply root cause analysis and corrective actions to resolve site process failures.
• Perform source data verification (SDV), source data review (SDR) and case report form (CRF) review.
• Assess investigational product inventory and documentation.
• Document findings in reports and letters, escalating issues to clinical management.
• Maintain regular communication with sites to ensure protocol adherence and timely data capture.
• Participate in investigator meetings, payment processes, and site initiation/close‑out activities.
• Ensure all essential documents meet ICH‑GCP and regulatory requirements.

Required profile

• Experience conducting clinical monitoring for pharmaceutical or biotech studies.
• Strong understanding of ICH‑GCP, regulatory guidelines, and SOPs.
• Ability to work independently, prioritize tasks, and manage multiple sites.
• Excellent written communication for reporting and correspondence.

Required skills

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