FSP CRA (Level II)

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 Level II Clinical Research Associate to monitor investigator sites using risk-based approaches, ensuring data accuracy and protocol compliance. The role involves on-site and remote monitoring activities, documentation, issue escalation, and coordination with clinical teams across investigational sites in Guangdong, China.

What they're looking for

Experience with root cause analysis and risk-based monitoring approaches
Proficiency in data verification methods including SDR, SDV, and CRF review
Knowledge of ICH-GCP guidelines and clinical trial regulations
Strong written and oral communication skills for regulatory and team interactions
Ability to manage multiple monitoring tasks and investigator site relationships
Familiarity with clinical trial management systems and documentation standards

What you'll be doing

Monitor investigator sites using risk-based approaches and apply corrective/preventive actions
Verify data accuracy through on-site and remote SDR, SDV, and CRF reviews
Document observations and escalate deficiencies to clinical management for resolution
Initiate trial sites, conduct close-out activities, and manage essential document compliance
Maintain communication between investigative sites, client company, and project teams

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Date posted8 days ago

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