Clinical Research Associate (Level II) – FSP Model

About the role

Thermo Fisher Scientific is seeking a Clinical Research Associate (Level II) to join its global monitoring team. You will support clinical trials by conducting remote or on‑site site visits, ensuring compliance with protocols, ICH‑GCP, and regulatory requirements.

Key responsibilities

• Perform risk‑based monitoring of investigator sites, applying root cause analysis and corrective actions.
• Verify data accuracy through source data verification (SDR), site data verification (SDV), and case report form (CRF) review.
• Assess investigational product inventory and documentation.
• Document observations in reports and letters, escalating deficiencies to clinical management.
• Maintain regular communication with sites to confirm protocol adherence and timely data capture.
• Execute monitoring tasks according to the approved monitoring plan and participate in investigator payment processes.
• Collaborate with project team members on issue resolution and follow‑up findings.
• Participate in investigator meetings and assist in identifying qualified investigative sites.

Required profile

• Experience in clinical site monitoring and management.
• Strong understanding of ICH‑GCP guidelines, regulatory compliance, and SOPs.
• Ability to conduct root cause analysis and implement corrective/preventive actions.
• Excellent written communication for timely reporting.

Required skills

• Risk‑based monitoring
• Root cause analysis
• Data review (SDR, SDV, CRF)
• Investigational product inventory management
• ICH‑GCP compliance
• Regulatory compliance
• SOP adherence

What we offer

• Opportunity to work on global clinical trials across 100+ countries.
• Inclusive workplace supporting LGBTQ+ community.
• Professional development within a leading scientific organization.