Clinical Research Associate I – Level II

About the role

As a Clinical Research Associate I (Level II) you will support the monitoring and management of investigator sites across multiple clinical trials. You will conduct both remote and on‑site visits to ensure compliance with protocols, regulatory requirements, and ICH‑GCP guidelines while safeguarding subject safety and data integrity.

Key responsibilities

• Perform risk‑based monitoring of investigator sites, applying root cause analysis and corrective actions.
• Execute source data verification (SDR), data verification (SDV), and case report form (CRF) review.
• Assess investigational product inventory and documentation.
• Document observations in reports and letters promptly, following business writing standards.
• Escalate deficiencies to clinical management and track resolution.
• Maintain regular communication with sites to confirm protocol adherence and timely data capture.
• Participate in investigator payment processes and meetings.
• Assist in site initiation, compliance verification, and trial close‑out activities.

Required profile

• Experience in clinical monitoring and site management.
• Familiarity with ICH‑GCP, regulatory guidelines, and SOPs.
• Ability to conduct both remote and on‑site monitoring visits.
• Strong documentation and reporting capabilities.

Required skills

• Source Data Verification (SDR)
• Data Verification (SDV)
• Case Report Form (CRF) review
• Root cause analysis
• Risk‑based monitoring approach