Clinical Research Associate I (CRA Level I)

About the role

We are seeking a Clinical Research Associate I to support monitoring and site management for clinical trials across multiple countries. The role involves conducting remote and on‑site visits, ensuring compliance with the study protocol, ICH‑GCP guidelines, and applicable regulatory requirements.

Key responsibilities

• Perform risk‑based monitoring of investigator sites, applying root cause analysis and corrective actions.
• Execute source data verification (SDV), source data review (SDR), and case report form (CRF) review.
• Assess investigational product inventory and documentation.
• Document observations in reports and letters following approved business writing standards.
• Escalate deficiencies to clinical management and follow issues through to resolution.
• Maintain regular contact with sites to confirm protocol adherence and timely data capture.
• Participate in investigator payment processes and investigator meetings.
• Assist in identifying qualified investigative sites and initiating site set‑up.
• Conduct trial close‑out activities and ensure essential documents are complete.

Required profile

• Strong analytical and problem‑solving abilities.
• Excellent written and verbal communication skills.
• Detail‑oriented with a focus on regulatory compliance.

Required skills

• Knowledge of ICH‑GCP guidelines.
• Experience with root cause analysis (RCA).
• Proficiency in source data verification (SDV) and source data review (SDR).
• Familiarity with case report form (CRF) review processes.