FSP CRA II
Thermo Fisher Scientific · Kuala Lumpur, Malaysia
RoleLantern re-checked this role's application link recently and it was active — the employer has not confirmed it directly.
Role summary
Thermo Fisher Scientific seeks a Clinical Research Associate Level II to monitor investigational sites and manage clinical trial operations across multiple sponsors. The role involves conducting remote and on-site visits to ensure protocol compliance, assess data quality, and maintain regulatory standards for clinical trials.
What they're looking for
- Bachelor's degree in life science or registered nursing certification with equivalent qualification
- Minimum one year clinical research monitoring experience or completion of drug development fellowship
- Proven clinical monitoring skills and working knowledge of ICH-GCP guidelines
- Strong critical thinking, root cause analysis, and risk-based monitoring expertise
- Excellent written and oral communication abilities with medical professionals
- Valid driver's license where applicable
- Attention to detail, organizational skills, and ability to work independently or in teams
What you'll be doing
- Conduct risk-based site monitoring visits remotely or on-site to assess protocol and regulatory compliance
- Review source data, case report forms, and investigational product inventories; document findings in reports
- Identify site process failures and implement corrective/preventive actions to reduce compliance risks
- Initiate and close out clinical trial sites; ensure essential documents are complete per ICH-GCP requirements
- Facilitate communication between investigative sites, sponsor companies, and project teams; provide trial status updates
Privacy & handoff
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