FSP CRA (Level II)

Thermo Fisher Scientific · Zhejiang, China

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Clinical OperationsFull timeCompany career page

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Role summary

Thermo Fisher Scientific seeks a Clinical Research Associate (Level II) to monitor investigational sites, ensure protocol compliance, and manage clinical trial documentation. The role involves on-site and remote monitoring activities, risk-based assessments, and coordination with study sites to maintain data integrity and regulatory compliance.

What they're looking for

Bachelor's degree in life sciences or registered nursing certification
Approximately 1 year clinical research monitoring experience or PPD fellowship completion
Proficient understanding of ICH-GCP guidelines and applicable regulations
Strong critical thinking and root cause analysis capabilities
Risk-based monitoring knowledge and experience
Excellent oral and written communication skills
Valid driver's license where applicable

What you'll be doing

Conduct on-site and remote monitoring visits using risk-based approach to assess compliance and data accuracy
Review case report forms, source documents and investigational product records to identify deficiencies
Initiate clinical trial sites, conduct investigator meetings and facilitate trial closeout procedures
Escalate findings and follow-up on resolution; prepare monitoring reports and status updates
Maintain communication between investigative sites, sponsors and project team members

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Date posted10 days ago

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