Clinical Research Associate (Level II)

About the role

Join a global team that supports leading pharmaceutical companies and biotechs in delivering clinical trials across more than 100 countries. As a Clinical Research Associate (Level II) you will conduct remote or on‑site monitoring visits, ensure protocol compliance, and manage essential documentation to protect subject safety and data integrity.

Key responsibilities

• Perform risk‑based monitoring of investigator sites, applying root cause analysis to identify and correct 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 maintain related records.
• Document observations in reports and letters, escalating deficiencies to clinical management and following issues to resolution.
• Maintain regular communication with sites to confirm protocol adherence and timely data capture.
• Participate in investigator payment processing and investigator meetings as needed.
• Identify and qualify potential investigators in collaboration with the client.
• Initiate site set‑up, ensure compliance with ICH‑GCP and regulatory requirements, and conduct trial close‑out activities.

Required profile

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

Required skills

• Risk‑based monitoring
• Root cause analysis
• Source data verification (SDR)
• Source data review (SDV)
• CRF review
• Investigational product inventory management
• Regulatory compliance
• ICH‑GCP knowledge
• Audit readiness