Clinical Research Associate II / Site Management Associate (NSW/VIC/QLD)
syneoshealth · AUS-Remote
Job description
About the role
Syneos Health is seeking a CRA II / SCRA to support real‑world late‑phase studies across NSW, VIC and QLD. The role involves site qualification, monitoring, data verification and investigational product management, either on‑site or remotely.
Key responsibilities
- Perform site qualification, initiation, interim monitoring, and close‑out visits ensuring compliance with ICH‑GCP, GPP and protocol requirements.
- Review source documents, verify data entry in CRFs, resolve queries and ensure electronic data capture compliance.
- Manage investigational product inventory, reconciliation, storage, and dispensing according to protocol.
- Maintain Investigator Site Files, reconcile with Trial Master Files, and support audit readiness.
- Support subject recruitment, retention, and documentation of all monitoring activities.
Required profile
- Bachelor’s degree or RN in a related field, or equivalent experience.
- Knowledge of Good Clinical Practice, ICH guidelines and relevant regulatory requirements.
- Excellent communication and interpersonal skills with ability to travel up to 75%.
- Ability to adapt quickly to changing priorities and manage site‑level activities.
Required skills
- Good Clinical Practice (GCP) and ICH guideline expertise.
- Electronic Data Capture (EDC) systems proficiency.
- Source document review and data verification techniques.
- Investigational product handling and inventory management.
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Published 19 hours ago
Expires 1 month from now
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syneoshealth
AUS-Remote
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