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Clinical Research Associate II / Site Management Associate (NSW/VIC/QLD)

syneoshealth · AUS-Remote

New Remote
Remote 🇬🇧 English
ICH guidelines Source document review

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.

Questions fréquentes

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Source : ats:workday

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Published 19 hours ago

Expires 1 month from now

5 views · 0 interested

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syneoshealth

AUS-Remote