Clinical Research Associate (Level II) – Clinical Monitoring

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 and site management activities, ensuring trials are conducted in compliance with protocols, ICH‑GCP, and regulatory requirements.

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 and correct site process failures.
• Verify data accuracy through source data verification (SDR), source data review (SDV), and case report form (CRF) review.
• Assess investigational product inventory and documentation.
• Document observations, prepare reports and letters, and escalate deficiencies to clinical management.
• Maintain regular communication with investigative sites to ensure protocol adherence and timely data capture.
• Participate in investigator payment processes and investigator meetings.
• Identify and qualify potential investigators in collaboration with the client.
• Initiate trial sites, conduct close‑out activities, and ensure essential documents are complete.

Required profile

• Experience in clinical monitoring or site management within pharmaceutical/biotech trials.
• Strong understanding of ICH‑GCP, regulatory guidelines, and SOPs.
• Ability to conduct root cause analysis and implement corrective actions.
• Excellent written communication for reporting and documentation.

Required skills

• Risk‑based monitoring methodology
• Source data verification (SDR) and source data review (SDV)
• Case report form (CRF) review
• Investigational product inventory management
• Regulatory compliance (ICH‑GCP)

What we offer

• Opportunity to work on a diverse portfolio of clinical trials worldwide.
• Collaborative environment with cross‑functional teams.
• Professional development in clinical research and monitoring.