Clinical Research Associate I – Site Monitoring

About the role

Join a global CRO team that supports leading pharmaceutical and biotech companies. As a Clinical Research Associate I you will monitor investigator sites, ensure compliance with protocols and regulations, and contribute to high‑quality data collection for clinical trials.

Key responsibilities

• Perform remote and on‑site monitoring visits using a risk‑based approach.
• Apply root cause analysis to identify site process failures and implement corrective actions.
• Verify source data (SDR/SDV) and review case report forms for accuracy.
• Assess investigational product inventory and documentation.
• Document findings in reports and letters, escalating issues to clinical management.
• Maintain regular communication with sites to resolve outstanding findings.
• Participate in investigator meetings, payment processes, and site initiation activities.
• Support trial close‑out and ensure essential documents are complete per ICH‑GCP.

Required profile

• Entry‑level experience or academic background in clinical research, life sciences, or related field.
• Strong analytical and problem‑solving abilities.
• Excellent written communication and documentation skills.
• Ability to work independently and collaborate with cross‑functional teams.

Required skills

• Knowledge of ICH‑GCP guidelines.
• Risk‑based monitoring methodology.
• Root cause analysis techniques.
• Source data verification (SDV) and source data review (SDR).
• Case report form (CRF) review.
• Investigational product inventory management.