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Clinical Research Associate – Future Roles (Australia)

Syneos Health · Adélaïde

🇬🇧 English
Good Pharmacoepidemiological Practices (GPP) Source document review Query resolution techniques

Job description

About the role

Syneos Health is seeking a Clinical Research Associate (CRA) for future‑focused roles in Australia. The CRA will support clinical trial sites through qualification, initiation, monitoring, management and close‑out activities, ensuring compliance with regulatory and ethical standards.

Key responsibilities

  • Perform site qualification, initiation, interim monitoring, management and close‑out visits (on‑site or remotely).
  • Ensure compliance with ICH‑GCP, Good Pharmacoepidemiological Practices (GPP) and protocol requirements.
  • Evaluate site performance, provide recommendations, and promptly communicate serious issues.
  • Verify informed consent processes and protect patient confidentiality.
  • Assess safety and data integrity risks, including protocol deviations and pharmacovigilance issues.
  • Conduct source document review and confirm accurate CRF data entry.
  • Apply query‑resolution techniques and guide site staff to close queries within timelines.
  • Utilize hardware and software tools to support effective site monitoring.

Required profile

  • Demonstrated experience in clinical monitoring or site management.
  • Strong knowledge of ICH‑GCP guidelines and applicable regulatory requirements.
  • Ability to assess site processes, identify risks and develop corrective actions.
  • Excellent attention to detail and documentation accuracy.
  • Effective communication skills for escalating issues and providing guidance.

Required skills

  • ICH‑GCP guidelines
  • Good Pharmacoepidemiological Practices (GPP)
  • Source document review
  • Case Report Form (CRF) data entry
  • Query resolution techniques
  • Regulatory compliance

What we offer

  • Career development and progression opportunities.
  • Supportive line management and peer recognition.
  • Technical and therapeutic area training.
  • Total rewards program and inclusive Total Self culture.

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Published 3 months ago

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Syneos Health

Adélaïde