Senior CRA level II
Thermo Fisher Scientific · Prague, Czechia
Clinical OperationsFull timeCompany career page
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Role summary
Thermo Fisher Scientific seeks a Senior Clinical Research Associate (Level II) to conduct remote and on-site clinical trial monitoring, ensure regulatory compliance, and manage site relationships. The role involves protocol oversight, data quality assurance, audit readiness, and mentoring of junior team members across multiple investigational sites.
What they're looking for
- Bachelor's degree in life science or registered nursing certification
- 3+ years clinical research monitoring experience or equivalent
- Strong FDA guidelines and ICH-GCP knowledge with demonstrated application
- Critical thinking, root cause analysis, and problem-solving capabilities
- Risk-based monitoring concepts and processes expertise
- Medical data evaluation skills and medical terminology proficiency
- Valid driver's license where applicable
What you'll be doing
- Conduct risk-based site monitoring visits, perform SDV/CRF reviews, and ensure data accuracy
- Identify site compliance deficiencies, apply root cause analysis, and drive corrective actions
- Initiate and close out clinical trial sites according to regulatory procedures and ICH-GCP requirements
- Mentor junior clinical team members and contribute to project documentation and training materials
- Provide trial status updates, maintain CTMS records, and facilitate communication across sites and sponsors
Privacy & handoff
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