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Clinical Research Associate (CRA II/Sr) – Remote – Santiago

Syneos Health

Remote
Remote Mid 🇬🇧 English
Good Pharmacoepidemiology Practice Source document review Query resolution

Job description

About the role

Syneos Health is seeking an experienced Clinical Research Associate (CRA II or Senior CRA) to join its sponsor‑dedicated team. This remote position supports clinical sites in Santiago while ensuring compliance with regulatory and protocol requirements.

Key responsibilities

  • Perform site qualification, initiation, interim monitoring, management activities and close‑out visits, either on‑site or remotely.
  • Evaluate overall site performance, provide recommendations, and promptly communicate serious issues to the project team.
  • Verify informed consent processes, protect patient confidentiality, and assess safety and data integrity risks.
  • Conduct source document review, ensure accurate CRF data entry, and resolve queries within agreed timelines.
  • Apply ICH/GCP guidelines, Good Pharmacoepidemiology Practice (GPP), and company SOPs throughout monitoring activities.

Required profile

  • Minimum 3 years of experience in clinical monitoring.
  • Strong knowledge of ICH/GCP guidelines and relevant regulatory requirements.
  • Ability to assess site processes, identify deviations, and develop corrective action plans.
  • Excellent communication skills for interacting with site staff and internal teams.

Required skills

  • ICH/GCP compliance
  • Good Pharmacoepidemiology Practice (GPP)
  • Source document review
  • Case Report Form (CRF) verification
  • Query resolution techniques
  • Pharmacovigilance awareness

What we offer

  • Career development and progression opportunities.
  • Supportive line management and peer recognition programs.
  • Access to technical and therapeutic area training.
  • Inclusive Total Self culture promoting authenticity and belonging.

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Published 1 month ago

Expires 32 minutes from now

30 views · 0 interested

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Syneos Health