Sr CRA (Level I) - FSP
Thermo Fisher Scientific
Thermo Fisher Scientific seeks a Senior Clinical Research Associate (Level I) to lead remote and on-site clinical trial monitoring activities. The role involves managing protocol compliance, site audits, data integrity, and regulatory documentation across multiple therapeutic sponsors globally.
Responsibilities
- Conduct on-site and remote monitoring visits to assess protocol compliance and regulatory adherence
- Perform data accuracy reviews including source document review and case report form verification
- Identify site process failures and implement corrective and preventive actions
- Prepare monitoring reports and escalate deficiencies to clinical management
- Maintain communication with investigational sites between visits and support trial closeout activities
Requirements
- Bachelor's degree in life sciences or Registered Nursing certification
- Minimum 3 years of completed on-site clinical monitoring experience
- Minimum 2 years as lead CRA on Oncology and/or Hematology trials
- Strong knowledge of ICH-GCP guidelines and applicable regulations
- Risk-based monitoring expertise and root cause analysis capabilities
- Excellent written and oral communication skills
- Critical thinking and problem-solving abilities
Vacante publicada el hace un mes
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