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Clinical Research Associate
Novartis
New South Wales, AUS
Full-time
Onsite
Discovered 1 weeks ago
Clinical researchClinical site monitoringClinical trial managementCentral or in-house monitoringICH/GCPClinical study protocols
Free
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Clinical researchClinical site monitoringClinical trial management
Role Overview
Join a team of Clinical Research Associates supporting patient-care transformation through clinical trials.
Ensure sustainable trial execution at sites through on-site and remote monitoring of Phase I–IV trials.
Perform monitoring in accordance with ICH/GCP, local regulations, monitoring procedures, and SOPs.
The role is based in any city in Australia and does not offer relocation support.
Key Skills for This Role
Clinical researchClinical site monitoringClinical trial managementCentral or in-house monitoringICH/GCPClinical study protocols
Full Job Posting
Role overview
Join a team of Clinical Research Associates supporting patient-care transformation through clinical trials.
Ensure sustainable trial execution at sites through on-site and remote monitoring of Phase I–IV trials.
Perform monitoring in accordance with ICH/GCP, local regulations, monitoring procedures, and SOPs.
The role is based in any city in Australia and does not offer relocation support.
Key responsibilities
- Act as the frontline liaison between Novartis and sites and manage assigned study sites against milestones and deliverables.
- Perform Site Initiation Visits and train site personnel on trial-related requirements.
- Conduct continuous site monitoring and retraining for amendments or new site personnel.
- Implement site-management activities to ensure protocol compliance.
- Identify process deficiencies and collaborate on risk mitigation and process improvement.
- Engage sites early on patient inventory and patient flow issues.
- Perform Site Closeout activities according to SOPs and applicable regulations.
- Participate in required onboarding, disease-indication, project-specific, and CRA training.
- Collaborate with the Clinical Project Manager, CRA Manager, internal stakeholders, and site personnel.
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