Clinical Research Associate I

About the role

Join a global team that supports leading pharmaceutical and biotech companies across more than 100 countries. As a Clinical Research Associate (Level II) you will coordinate and execute clinical monitoring and site management activities, ensuring trials are conducted in compliance with protocols, ICH‑GCP, and regulatory requirements.

Key responsibilities

• Perform remote or on‑site monitoring visits using a risk‑based approach.
• Apply root cause analysis, critical thinking, and problem‑solving to identify and correct site process failures.
• Verify data accuracy through source data verification (SDR), SDV, and CRF review.
• Assess investigational product inventory and documentation.
• Document observations, generate reports, and communicate findings promptly.
• Escalate deficiencies to clinical management and follow issues through to resolution.
• Maintain regular contact with investigative sites to ensure protocol adherence and timely data capture.
• Participate in investigator payment processes and investigator meetings.
• Identify and qualify new investigative sites in collaboration with the client.
• Initiate trial sites, conduct close‑out activities, and ensure essential documents are complete.

Required profile

• Strong knowledge of ICH‑GCP guidelines and regulatory requirements.
• Experience with risk‑based monitoring and root cause analysis.
• Ability to conduct both remote and on‑site monitoring visits.
• Excellent written communication for timely reporting.

Required skills

• ICH‑GCP compliance
• Risk‑based monitoring
• Root cause analysis (RCA)
• Source data verification (SDR) and source data review (SDV)
• Clinical trial documentation management

What we offer

• Opportunity to work on high‑impact clinical trials for top pharma and biotech companies.
• Collaborative environment with global exposure.
• Professional development in clinical research monitoring.