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Clinical Research Associate II – Sponsor Dedicated

syneoshealth · ARG-Buenos Aires

New
Mid 🇬🇧 English
ICH guidelines Source document review

Job description

About the role

Syneos Health is seeking a Clinical Research Associate II to support sponsor‑dedicated studies in Argentina. The CRA II will manage site activities throughout the study lifecycle, ensuring compliance with regulatory and protocol requirements.

Key responsibilities

  • Perform site qualification, initiation, monitoring, management and close‑out visits, both on‑site and remotely.
  • Review source documents, verify data entry in case report forms, and resolve queries to closure.
  • Manage investigational product inventory, reconciliation, storage, and dispensing according to protocol.
  • Document activities through trip reports, letters, and logs in line with SOPs and monitoring plans.
  • Support subject recruitment, retention, and awareness strategies and track observations in study systems.

Required profile

  • Bachelor’s degree or RN in a related field, or equivalent experience.
  • Knowledge of Good Clinical Practice (GCP) and ICH guidelines, and ability to apply local 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 within project scope.

Required skills

  • Good Clinical Practice (GCP) knowledge
  • ICH guideline familiarity
  • Source document review and data verification
  • Investigational product handling and reconciliation
  • Use of electronic data capture (EDC) systems

Questions fréquentes

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Source : ats:workday

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Published 4 hours ago

Expires 1 month from now

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syneoshealth

ARG-Buenos Aires