FSP CRA I

Thermo Fisher Scientific · Guangdong, China

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Clinical OperationsFull timeCompany career page

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Role summary

Thermo Fisher Scientific seeks a Clinical Research Associate to conduct clinical trial monitoring and site management across multiple protocols. The role involves remote and on-site visits to assess compliance, manage documentation, and ensure data integrity across investigational sites in accordance with ICH-GCP guidelines.

What they're looking for

Bachelor's degree in life sciences or registered nursing certification
Approximately one year clinical research monitoring experience or PPD fellowship completion
Demonstrated knowledge of ICH-GCP guidelines and applicable regulations
Strong critical thinking, root cause analysis, and problem-solving capabilities
Proficiency in risk-based monitoring concepts and processes
Excellent oral and written communication skills
Valid driver's license where applicable

What you'll be doing

Conduct risk-based monitoring visits to assess protocol compliance and regulatory adherence at investigational sites
Review source documents, case report forms, and investigational product records; document findings and escalate deficiencies
Facilitate investigator meetings and site initiation/closeout activities per approved procedures
Maintain essential regulatory documentation and conduct on-site file reviews
Provide trial status updates and coordinate communication between sites, clients, and project team

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Date posted8 days ago

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