Sr CRA (Level I)
Thermo Fisher Scientific · Beijing, China
RoleLantern re-checked this role's application link recently and it was active — the employer has not confirmed it directly.
Role summary
Senior Clinical Research Associate at Thermo Fisher Scientific responsible for monitoring investigational sites, ensuring protocol compliance, and managing clinical trial documentation. Conducts on-site and remote monitoring visits to assess regulatory adherence, data quality, and subject safety across global clinical trials.
What they're looking for
- Bachelor's degree in life sciences or registered nursing certification
- Approximately one year clinical research monitoring experience or PPD fellowship completion
- Demonstrated understanding of ICH-GCP guidelines and applicable regulations
- Proven critical thinking, root cause analysis, and problem-solving abilities
- Strong oral and written communication skills with medical personnel
- Risk-based monitoring expertise and knowledge of medical terminology
- Valid driver's license where applicable
What you'll be doing
- Monitor investigational sites using risk-based approach; conduct SDR, SDV, and CRF reviews
- Identify protocol deviations and non-compliance; perform root cause analysis and implement corrective actions
- Conduct investigator meetings, initiate trial sites, and perform trial closeout procedures
- Ensure critical documents are complete per ICH-GCP; provide trial status updates to clinical management
- Facilitate communication between sites, sponsors, and project team; respond to audits and regulatory inspections
Privacy & handoff
This role links to Thermo Fisher Scientific's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.