Sr CRA I/II - FSP - Germany
Thermo Fisher Scientific · Remote
RoleLantern re-checked this role's application link recently and it was active — the employer has not confirmed it directly.
Role summary
Thermo Fisher Scientific seeks a Senior Clinical Research Associate to monitor investigator sites using risk-based approaches, ensure data accuracy, and manage clinical trial compliance across multiple sites. The role involves on-site and remote monitoring, regulatory coordination, and cross-functional collaboration within a global clinical operations team.
What they're looking for
- Bachelor's degree in life science or registered nursing certification with equivalent qualification
- Minimum 3 years experience as a Clinical Research Associate
- At least 2 years hands-on, on-site cell therapy experience
- Strong understanding of ICH GCP guidelines, regulations, and risk-based monitoring
- Demonstrated critical thinking and root cause analysis skills
- Proficient written and oral communication in English with strong presentation abilities
- Proficiency in Microsoft Office and ability to learn clinical trial management systems
What you'll be doing
- Monitor investigator sites using risk-based approach; identify deficiencies and implement corrective/preventive actions
- Conduct source data review, verification, and case report form reviews via on-site and remote monitoring
- Perform physical inventory assessments of investigational products and document findings in reports
- Provide trial status updates and progress reports to Clinical Team Manager; maintain CTMS system accuracy
- Participate in investigator meetings, site initiation, and trial closeout activities; facilitate multi-party communication
Privacy & handoff
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