FSP Clinical Research Associate – Hong Kong
Thermo Fisher Scientific · RAS Hong Kong
Job description
About the role
Thermo Fisher Scientific is seeking a Clinical Research Associate (FSP) to support clinical monitoring and site management for studies conducted in Hong Kong. The role involves both remote and on‑site visits to ensure protocol compliance, data accuracy and regulatory adherence.
Key responsibilities
- Perform risk‑based monitoring of investigator sites, applying root‑cause analysis and corrective actions.
- Conduct source data verification (SDR), source data validation (SDV) and case report form (CRF) review.
- Assess investigational product inventory and documentation.
- Document observations in reports and letters following business writing standards.
- Escalate deficiencies to clinical management and follow issues through to resolution.
- Maintain regular contact with sites between visits to verify protocol adherence and timely data capture.
- Participate in investigator payment processes and trial status reporting.
Required profile
- Experience in clinical monitoring and site management.
- Knowledge of ICH‑GCP guidelines, regulatory requirements and SOPs.
- Ability to conduct both remote and on‑site monitoring activities.
- Strong analytical and problem‑solving skills, including root‑cause analysis.
Required skills
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Published 1 month ago
Expires 3 weeks from now
24 views · 0 interested
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Thermo Fisher Scientific
RAS Hong Kong
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