CRA I - Senior CRA (FSP)
Thermo Fisher Scientific · Adelaide, Australia
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 investigational sites, ensure protocol compliance, and manage clinical trial documentation. This home-based role in Western/Southern Australia involves remote and on-site activities to support data integrity and regulatory adherence across multiple trial sites.
What they're looking for
- Bachelor's degree in life sciences, nursing certification, or equivalent qualification
- Approximately one year clinical research monitoring experience or PPD Drug Development Fellowship completion
- Essential oncology therapeutic experience
- Strong understanding of ICH-GCP guidelines and applicable regulations
- Critical thinking and root cause analysis skills for problem-solving
- Proficiency in risk-based monitoring concepts and processes
- Valid driver's license where applicable
What you'll be doing
- Conduct on-site and remote monitoring visits using risk-based approach; perform source data reviews and CRF audits
- Identify protocol and regulatory compliance issues; document findings and escalate deficiencies to clinical management
- Initiate and close-out investigational sites; participate in investigator meetings and site qualification activities
- Maintain trial documentation completeness and verify investigational product inventory and records
- Provide trial status updates and progress reports to clinical leadership; facilitate communication between sites and project team
Privacy & handoff
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