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Clinical Research Associate II – Beijing

Syneos Health · Sumapaz

🇬🇧 English
Good Pharmacoepidemiology Practice clinical monitoring site management source document review pharmacovigilance

Job description

About the role

The Clinical Research Associate II (CRA II) will join Syneos Health’s Clinical Solutions team in Beijing. The role supports drug development projects by managing site activities from qualification through close‑out, ensuring compliance with regulatory and protocol requirements.

Key responsibilities

  • Perform site qualification, initiation, interim monitoring, site management and close‑out visits, either on‑site or remotely.
  • Ensure adherence to ICH‑GCP, Good Pharmacoepidemiology Practice (GPP) and study protocol.
  • Evaluate overall site performance, provide recommendations, and promptly escalate serious issues.
  • Verify that informed consent is obtained and documented correctly for each subject.
  • Protect subject confidentiality and assess safety or data‑integrity concerns such as protocol deviations and pharmacovigilance issues.
  • Conduct source document review of site records and medical charts as defined in the Clinical Monitoring/Site Management Plan.

Required profile

  • Proven experience in clinical monitoring or site management for pharmaceutical or CRO studies.
  • Strong knowledge of ICH‑GCP guidelines and applicable regulatory requirements.
  • Ability to assess site processes, identify risks and develop corrective action plans.
  • Excellent communication skills and sound judgment for issue escalation.

Required skills

  • ICH GCP
  • Good Pharmacoepidemiology Practice (GPP)
  • Clinical monitoring
  • Site management
  • Source document review
  • Informed consent verification
  • Pharmacovigilance awareness
  • Regulatory compliance

What we offer

  • Career development and progression opportunities.
  • Supportive line management and technical training.
  • Peer recognition and total rewards program.
  • Inclusive culture that encourages authenticity.

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Published 3 months ago

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Syneos Health

Sumapaz