Clinical Research Associate (Level II)

About the role

Join our global clinical research team as a Clinical Research Associate (Level II) and contribute to the successful execution of clinical trials across multiple therapeutic areas. You will perform remote and on‑site monitoring visits, ensuring compliance with protocols, regulations, and ICH‑GCP standards.

Key responsibilities

• Conduct risk‑based monitoring visits (remote or on‑site) to assess protocol adherence and regulatory compliance.
• Perform source data verification (SDR), source data review (SDV), and case report form (CRF) review as required.
• Review investigational product inventory and related documentation.
• Document findings in monitoring reports and letters, following approved business writing standards.
• Escalate deficiencies promptly and track resolution through to closure.
• Maintain regular communication with sites to ensure ongoing compliance and timely data capture.
• Participate in investigator meetings, payment processes, and site initiation activities.
• Support trial close‑out activities and retrieval of trial materials.

Required profile

• Experience with clinical monitoring and site management in a pharmaceutical or biotech environment.
• Strong understanding of ICH‑GCP guidelines and applicable regulatory requirements.
• Ability to apply root cause analysis, critical thinking, and problem‑solving to address site issues.
• Excellent written communication skills for clear reporting.

Required skills

• ICH‑GCP compliance
• Root Cause Analysis (RCA)
• Risk‑based monitoring
• Source Data Verification (SDR) and Source Data Review (SDV)
• Clinical trial documentation management