FSP Sr. CRA (Oncology & Cell Therapy)
Thermo Fisher Scientific · Remote
Clinical OperationsRemoteFull timeCompany career page
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Role summary
Thermo Fisher Scientific seeks a Senior Clinical Research Associate to monitor investigational sites for oncology and cell therapy trials. The role involves remote and on-site visits to ensure protocol compliance, data integrity, and regulatory adherence across clinical studies.
What they're looking for
- Bachelor's degree in life sciences or Registered Nursing certification
- 2+ years clinical research monitoring or equivalent experience
- Valid driver's license where applicable
- Risk-based monitoring and root cause analysis expertise
- Strong written and oral communication skills
- ICH-GCP and regulatory compliance knowledge
- Proficiency with clinical trial management systems
What you'll be doing
- Conduct on-site and remote monitoring visits applying risk-based approaches and CAPA strategies
- Perform SDV, CRF review, and investigational product accountability assessments
- Prepare monitoring reports, follow-up letters, and study documentation with timely escalation
- Mentor less experienced CRAs and serve as operational partner to project teams
- Support site identification, qualification, initiation, and close-out activities
Key requirements
- Therapeutic area
- Oncology
Privacy & handoff
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