Clinical Research Associate (Level II)

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 clinical monitoring activities, ensuring trials are conducted in compliance with protocols, regulations, and ICH‑GCP standards.

Key responsibilities

• Perform remote or on‑site monitoring visits using a risk‑based approach.
• Apply root cause analysis, critical thinking and problem‑solving to identify site process failures and implement corrective actions.
• Verify data accuracy through source data review (SDR), source data verification (SDV) and case report form (CRF) review.
• Assess investigational product inventory and documentation.
• Document observations in reports and letters, escalating deficiencies to clinical management and following through to resolution.
• Maintain regular communication with investigative sites to ensure protocol adherence and timely data capture.
• Participate in investigator payment processes and investigator meetings.
• Support site initiation, trial close‑out, and retrieval of trial materials.

Required profile

• Experience in clinical monitoring and site management.
• Strong knowledge of ICH‑GCP guidelines and applicable regulatory requirements.
• Ability to conduct both remote and on‑site visits and manage documentation.
• Excellent analytical skills for root cause analysis and problem resolution.

Required skills

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