Clinical Research Associate (Level II) – FSP

About the role

Join a global CRO 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, ICH‑GCP, and regulatory requirements.

Key responsibilities

• Perform remote and 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.
• Conduct source data verification (SDR), source data validation (SDV) and case report form (CRF) review.
• Assess investigational product inventory and documentation.
• Document observations in reports and letters, escalating deficiencies to clinical management.
• Maintain regular communication with investigative sites to ensure protocol adherence and timely data capture.
• Participate in investigator payment processing and investigator meetings.
• Support site initiation, trial close‑out, and retrieval of trial materials.

Required profile

• Experience conducting clinical monitoring visits (remote or on‑site) in a CRO or sponsor environment.
• Strong knowledge of ICH‑GCP, regulatory guidelines and SOPs.
• Ability to perform root cause analysis and develop corrective/preventive actions.
• Excellent written communication for reporting observations and escalations.

Required skills