CRA (Level II)
Thermo Fisher Scientific · Shanghai, China
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Role summary
Clinical Research Associate (Level II) at Thermo Fisher Scientific responsible for monitoring investigator sites, ensuring data accuracy, and maintaining regulatory compliance in clinical trials. The role involves on-site and remote monitoring activities, investigator site initiation, and coordination between study sites and project teams across clinical research operations.
What they're looking for
- Bachelor's degree in life sciences or Registered Nursing certification
- Approximately 1 year of clinical research monitoring experience
- Validated clinical monitoring skills and ICH GCP understanding
- Strong critical thinking and risk-based monitoring competency
- Proficient written and oral communication in English
- Medical/therapeutic area knowledge and medical terminology understanding
What you'll be doing
- Monitor investigator sites using risk-based approaches; perform data accuracy reviews through SDR, SDV, and CRF evaluation
- Conduct on-site and remote monitoring activities; document findings in compliance reports and communications
- Participate in investigator meetings, identify qualified sites, and initiate clinical trial sites per protocol requirements
- Track trial status and provide progress reports to Clinical Team Manager; maintain study system updates
- Facilitate communication between investigative sites, client companies, and project teams; respond to regulatory requirements
Privacy & handoff
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