Clinical Research Associate II (CRA Level II)

About the role

Join a global team that supports leading pharmaceutical companies and biotech firms across more than 100 countries. As a Clinical Research Associate II, you will coordinate and execute clinical monitoring activities, ensuring trials adhere to protocols, regulatory standards, and ICH‑GCP guidelines.

Key responsibilities

• Perform risk‑based monitoring of investigator sites, both on‑site and remotely.
• Apply root cause analysis and corrective actions to address site process failures.
• Conduct source data verification (SDR), source data review (SDV), 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 ensure protocol compliance and timely data recording.
• Participate in investigator meetings, payment processes, and site initiation/close‑out activities.

Required profile

• Experience in clinical monitoring and site management.
• Strong analytical and problem‑solving abilities.
• Familiarity with ICH‑GCP, SOPs, and regulatory requirements.
• Ability to work independently and collaborate with cross‑functional teams.

Required skills

• Risk‑based monitoring
• Root cause analysis (RCA)
• Source Data Verification (SDR)
• Source Data Review (SDV)
• Case Report Form (CRF) review
• ICH‑GCP compliance

What we offer

• Opportunity to work on diverse clinical trials across multiple countries.
• Collaboration with top‑tier pharmaceutical and biotech sponsors.