Clinical Research Associate II / Site Management Associate (NSW/VIC/QLD)
syneoshealth · AUS-Remote
Job description
About the role
Syneos Health is seeking a Clinical Research Associate II / Site Management Associate to support real‑world late‑phase studies across NSW, VIC and QLD. The role involves managing site activities from qualification through close‑out, ensuring compliance with regulatory and protocol requirements.
Key responsibilities
- Perform site qualification, initiation, monitoring, management and close‑out visits, both on‑site and remotely.
- Review source documents, verify data entry in CRFs, and resolve queries within agreed timelines.
- Manage investigational product inventory, reconciliation, storage, and dispensing according to protocol.
- Maintain Investigator Site Files, reconcile with Trial Master Files, and ensure proper archiving of essential documents.
- Document activities through letters, trip reports and logs, and support recruitment, retention and awareness strategies.
- Act as liaison with site personnel, attend investigator meetings and global monitoring meetings, and assist with audit readiness.
Required profile
- Bachelor’s degree or RN in a related field, or equivalent education and experience.
- Knowledge of Good Clinical Practice (GCP) / ICH guidelines and applicable regulatory requirements.
- Excellent communication, presentation and interpersonal skills.
- Willingness to travel up to 75% of the time.
Required skills
- Good Clinical Practice (GCP) and ICH guideline knowledge.
- Proficiency with electronic data capture systems and related software.
- Strong computer skills and ability to adopt new technologies.
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Published 7 hours ago
Expires 1 month from now
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syneoshealth
AUS-Remote
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