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Clinical Research Associate II (Peru)

Syneos Health · Lima et périphérie

🇬🇧 English
Site qualification Site initiation Interim monitoring Site management Source document review Pharmacovigilance ICH/GCP guidelines Good Pharmacoepidemiology Practice (GPP)

Job description

About the role

Syneos Health is seeking a Clinical Research Associate II to support clinical studies in Peru. You will work closely with investigators and internal teams to ensure sites meet regulatory, ICH‑GCP and protocol requirements while safeguarding patient safety and data integrity.

Key responsibilities

  • Perform site qualification, initiation, interim monitoring, management and close‑out visits, either on‑site or remotely.
  • Evaluate site performance, identify issues, and develop corrective action plans.
  • Verify informed consent processes and protect patient confidentiality.
  • Conduct source document review and assess protocol deviations, pharmacovigilance concerns, and data quality.
  • Maintain up‑to‑date knowledge of ICH/GCP guidelines, Good Pharmacoepidemiology Practice (GPP), relevant regulations and company SOPs.

Required profile

  • Strong understanding of clinical monitoring and site management activities.
  • Ability to use professional judgment to assess site performance and communicate issues promptly.
  • Attention to detail and commitment to patient safety and data integrity.
  • Effective communication skills for interaction with investigators, project teams and sponsors.

Required skills

  • Site qualification and initiation
  • Interim monitoring and site management
  • Close‑out visit execution
  • Source document review
  • Informed consent verification
  • Pharmacovigilance awareness
  • Knowledge of ICH/GCP guidelines
  • Good Pharmacoepidemiology Practice (GPP)
  • Regulatory compliance

What we offer

  • Career development and progression opportunities
  • Supportive line management and peer recognition
  • Technical and therapeutic area training
  • Inclusive culture with total rewards program

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Published 3 months ago

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Syneos Health

Lima et périphérie