Senior Clinical Research Associate (Level II)

About the role

Join a global team that supports leading pharmaceutical and biotech companies in delivering high‑quality clinical trials. As a Senior Clinical Research Associate (Level II), you will conduct remote and on‑site monitoring visits, ensuring protocol compliance, regulatory adherence, and data integrity across investigational sites.

Key responsibilities

• Perform risk‑based monitoring visits, applying root cause analysis to identify and correct site process failures.
• Verify source data (SDR) and conduct source data verification (SDV) as well as CRF review to ensure data accuracy.
• Assess investigational product inventory and documentation.
• Document observations in reports and letters, escalating deficiencies to clinical management and following through 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.
• Collaborate with project team members on issue resolution and trend analysis.

Required profile

• Senior‑level experience in clinical monitoring and site management.
• Strong understanding of ICH‑GCP guidelines, SOPs, and regulatory requirements.
• Ability to conduct both remote and on‑site monitoring activities.
• Excellent written communication skills for reporting and documentation.

Required skills

• Risk‑based monitoring
• Root cause analysis (RCA)
• Source data verification (SDV)
• Source data review (SDR)
• CRF review
• ICH‑GCP compliance