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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 NSW, VIC and QLD. The role involves site qualification, monitoring, data verification and investigational product oversight, 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 CRF data accuracy, resolve queries and maintain electronic data capture compliance.
  • Manage investigational product inventory, reconciliation, storage, and dispensing according to protocol.
  • Document activities through trip reports, confirmation letters and maintain Investigator Site Files in alignment with TMF standards.
  • Support recruitment, retention and patient awareness strategies, and act as liaison between site personnel and central monitoring teams.

Required profile

  • Bachelor’s degree or RN in a related field, or equivalent education and experience.
  • Strong knowledge of Good Clinical Practice, ICH Guidelines and relevant regulatory requirements.
  • Excellent communication and interpersonal skills with the ability to travel up to 75% of the time.
  • Ability to adapt quickly to changing priorities and manage site‑level activities to meet project timelines.

Required skills

  • Good computer skills and proficiency with electronic data capture systems.
  • Understanding of source document review and query resolution techniques.
  • Familiarity with investigational product handling and inventory management.

Questions fréquentes

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Source : ats:workday

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Published 14 hours ago

Expires 1 month from now

5 views · 0 interested

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syneoshealth

AUS-Remote