Clinical Research Associate (Level II) – Saudi Arabia

About the role

Join a global CRO team supporting leading pharmaceutical and biotech companies. As a Clinical Research Associate (Level II) you will monitor investigator sites in Saudi Arabia, ensuring trials are conducted according to protocol, ICH‑GCP, and local regulations.

Key responsibilities

• Perform risk‑based monitoring visits (remote or on‑site) to assess protocol compliance and data accuracy.
• Apply root cause analysis to identify site process failures and implement corrective actions.
• Conduct source data review (SDR), source data verification (SDV), and case report form (CRF) review.
• Assess investigational product inventory and documentation.
• Document findings in reports, letters, and escalation logs, following business writing standards.
• Maintain regular communication with sites to resolve outstanding issues and ensure timely data capture.
• Participate in investigator meetings, payment processes, and site initiation/close‑out activities.

Required profile

• Experience in clinical monitoring or site management, preferably at a mid‑level.
• Strong understanding of ICH‑GCP, local regulatory requirements, and SOPs.
• Ability to conduct root cause analysis and implement preventive actions.
• Excellent written communication and documentation skills.

Required skills

• Root cause analysis (RCA)
• Source data review (SDR)
• Source data verification (SDV)
• Case report form (CRF) review
• ICH‑GCP compliance