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Site Management Associate I

PSI CRO · Buenos Aires

Nuevo
🇬🇧 English
MS Office CTMS EDC

Descripcion del puesto

About the role

Join our international team as a Site Management Associate, providing key support to clinical research projects by streamlining communication, maintaining systems, and managing documents and information.

Key responsibilities

  • Act as the main point of contact between site personnel and CRA, assisting with query resolution and EDC completion.
  • Coordinate vendor interactions, study supplies, and access management for sites.
  • Ensure pre‑study testing of local site facilities (scans, MRI/CT qualification, ECGs) is completed.
  • Support monitors in completing subject and site event information in the CTMS.
  • Track resolution status of site issues and action items in the CTMS.
  • Manage ordering, receipt, inventory, distribution, and reconciliation of clinical supplies.
  • Oversee regulatory and ethics committee submissions, staying up‑to‑date on local regulations.
  • Prepare for and follow up on site, TMF, and systems audits and inspections.
  • Maintain the TMF at site and country level, filing documents regularly.
  • Prepare, distribute, and update Investigator Site Files (ISF) and checklists.

Required profile

  • College/University degree in Life Sciences.
  • Administrative work experience, preferably in an international setting.
  • Prior experience as a Clinical Trial Assistant (CTA) for CROs.
  • Experience in clinical research and knowledge of local regulations.
  • Full professional proficiency in English.
  • Proficiency with MS Office applications.

Required skills

  • MS Office
  • CTMS
  • EDC

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PSI CRO

Buenos Aires