FSP Sr CRA (Level I)

Thermo Fisher Scientific · Shanghai, China

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Clinical OperationsFull timeCompany career page

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Role summary

Thermo Fisher Scientific seeks a Senior Clinical Research Associate to monitor investigational sites, ensure protocol compliance, and manage clinical trial documentation. The role involves remote and on-site visits, risk-based monitoring, and coordination with sponsors and sites across multiple trials.

What they're looking for

Bachelor's degree in life sciences or registered nursing certification
Approximately one year clinical research monitoring experience or fellowship completion
Proficiency in ICH-GCP guidelines, regulations, and clinical monitoring procedures
Strong critical thinking, root cause analysis, and problem-solving abilities
Excellent oral and written communication skills with medical personnel
Expertise in risk-based monitoring concepts and data verification methods
Valid driver's license where applicable

What you'll be doing

Conduct remote and on-site monitoring visits to assess protocol compliance and regulatory adherence
Perform source document review, verification, and investigational product inventory assessments
Identify site process failures and implement corrective and preventive actions
Initiate clinical trial sites and conduct trial closeout procedures
Provide trial status updates and maintain clinical trial management system records

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Date posted7 days ago

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