Clinical Research Associate (Level II)

About the role

Join a global team that supports leading pharmaceutical and biotech companies in delivering clinical trials across the world. As a Clinical Research Associate (Level II) you will conduct remote or on‑site monitoring visits, ensure protocol compliance, and safeguard subject safety and data integrity.

Key responsibilities

• Perform risk‑based monitoring of investigator sites, applying root cause analysis to identify and correct process failures.
• Execute source data verification (SDV), source data review (SDR) and case report form (CRF) review to ensure data accuracy.
• Assess investigational product inventory and documentation.
• Document observations in reports and letters promptly, following approved business writing standards.
• Escalate deficiencies to clinical management and follow issues through to resolution.
• Maintain regular contact with sites between visits to verify protocol adherence and timely data capture.
• Participate in investigator payment processes and investigator meetings as needed.
• Initiate new trial sites, ensure essential documents are complete, and conduct trial close‑out activities.

Required profile

• Mid‑level experience in clinical monitoring or site management.
• Strong understanding of ICH‑GCP guidelines and applicable regulations.
• Ability to apply critical thinking and problem‑solving skills in a fast‑paced environment.
• Excellent written communication for reporting and correspondence.
• Proactive attitude toward audit readiness and collaborative relationship building with sites.

Required skills

• ICH‑GCP
• Root cause analysis
• Clinical monitoring
• Source data verification (SDV)
• Source data review (SDR)
• Case report form (CRF) review
• Risk‑based monitoring