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

syneoshealth · AUS-Remote

New Remote
Remote 🇬🇧 English
ICH guidelines

Job description

About the role

Syneos Health is seeking a CRA II / SCRA to support real‑world late‑phase studies across New South Wales, Victoria and Queensland. The role involves site qualification, initiation, monitoring, and close‑out activities, both on‑site and remotely, ensuring compliance with ICH‑GCP and protocol requirements.

Key responsibilities

  • Perform site qualification, initiation, interim monitoring, and close‑out visits, evaluating site performance and escalating serious issues.
  • 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 document activities through letters, reports, and logs.
  • Support subject recruitment, retention, and awareness strategies while tracking observations and action items.

Required profile

  • Bachelor’s degree or RN in a related field, or equivalent experience.
  • Knowledge of Good Clinical Practice (GCP) and ICH guidelines.
  • Excellent communication and interpersonal skills with the ability to travel up to 75%.
  • Ability to adapt quickly to changing priorities and manage site‑level activities.

Required skills

  • Good Clinical Practice (GCP) compliance
  • ICH guideline familiarity
  • Electronic Data Capture (EDC) systems
  • Strong computer proficiency and willingness to adopt new technologies

Questions fréquentes

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Source : ats:workday

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Published 19 hours ago

Expires 1 month from now

6 views · 0 interested

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syneoshealth

AUS-Remote