FSP CRA(Level II)

Thermo Fisher Scientific · Sichuan, China

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Clinical OperationsFull timeCompany career page

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Role summary

Clinical Research Associate (Level II) position at Thermo Fisher Scientific in Chengdu, supporting pharmaceutical and biotech clinical trials. The role involves remote and on-site monitoring of investigational sites, ensuring protocol compliance, managing documentation, and coordinating site activities across multiple sponsors.

What they're looking for

Bachelor's degree in life sciences or registered nursing certification
Approximately 1 year clinical research monitoring experience or PPD Drug Development Fellowship completion
Strong knowledge of ICH-GCP guidelines and applicable regulations
Demonstrated critical thinking, root cause analysis, and problem-solving capabilities
Proficiency with risk-based monitoring concepts and processes
Excellent written and oral communication skills
Valid driver's license where applicable

What you'll be doing

Conduct on-site and remote monitoring visits to assess protocol and regulatory compliance at investigational sites
Perform source document review (SDR), source document verification (SDV), and case report form (CRF) review
Identify site process failures and develop corrective and preventive actions to achieve compliance
Initiate clinical trial sites, facilitate investigator meetings, and manage trial closeout procedures
Document observations in monitoring reports and escalate deficiencies to clinical management for resolution

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Date posted10 days ago

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