FSP Clinical Research Associate (CRA) – Hong Kong

About the role

Thermo Fisher Scientific is seeking a Clinical Research Associate (CRA) to join its FSP team in Hong Kong. The CRA will be responsible for monitoring investigator sites, ensuring compliance with protocols, ICH‑GCP guidelines and regulatory requirements, and supporting the delivery of high‑quality clinical trial data.

Key responsibilities

• Perform remote and on‑site monitoring visits using a risk‑based approach, applying root cause analysis to identify and resolve site process failures.
• Review source data, perform source data verification (SDR), and conduct case report form (CRF) checks to ensure data accuracy.
• Assess investigational product inventory and documentation, and document observations in reports and letters following business writing standards.
• Escalate deficiencies promptly, track corrective actions, and follow issues through to resolution.
• Maintain regular communication with sites between visits to verify protocol adherence and timely data capture.
• Participate in investigator payment processes and provide trial status updates to the Clinical Team Manager.
• Ensure audit readiness and compliance with sponsor, FSO, FSP and governmental guidelines.

Required profile

• Experience in clinical monitoring and site management.
• Strong knowledge of ICH‑GCP, regulatory compliance and SOPs.
• Ability to conduct both remote and on‑site visits and to work collaboratively with investigational sites.
• Excellent written communication for timely reporting of findings.

Required skills

• Root cause analysis (RCA)
• Data review (SDR, SDV, CRF)