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Thermo Fisher Scientific

CRA (Level II)

Posted an hour ago

Vietnam

2-5 years experience

compliance

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AI Summary

Performs and coordinates all aspects of the clinical monitoring and site management process to ensure protocol and regulatory compliance. Acts as a site processes specialist to guarantee subject rights, well-being, and data reliability while maintaining audit readiness.

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Performs and coordinates all aspects of the clinical monitoring and site management process. Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation. Manages procedures and guidelines from different sponsors and/or monitoring environments (i.e. FSO, FSP, Government, etc.). Acts as a site processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs to guarantee subjects rights, well-being and data reliability. Ensures audit readiness. Develops collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to role
are outlined in the task matrix.