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Clinical Research Site Coordinator

hace 1 mes

Buenos Aires, Buenos Aires C.F., Argentina PSI A tiempo completo

About the Role

We are seeking a highly skilled Clinical Research Site Coordinator to join our international team at PSI. In this key support role, you will streamline communication, maintain systems, and manage documents and information for clinical research projects.

The successful candidate will be responsible for:

  • Acting as the main point of contact between site personnel and CRA involved in the project, helping with query resolution and EDC completion.
  • Serving as the primary site's contact point for vendors, study supplies, and access management.
  • Ensuring that pre-study testing (scans, MRI/CT qualification questionnaires, test ECGs, etc.) of local site facilities is completed.
  • Assisting monitors in completing subject event and site event information in CTMS, tracking resolution status of site issues and action items.
  • Coordinating the order, receipt, inventory storage, distribution, return/recall, and reconciliation of clinical supplies.
  • Managing regulatory and ethics committee submissions and notifications, ensuring up-to-date knowledge of local regulations.
  • Preparing for and following up on site, TMF, and system audits and inspections.
  • Managing the TMF on a site and country level, filing documents, preparing and distributing Investigator Site Files (ISF), and ISF checklists.
  • Arranging and tracking initial and ongoing project training for site teams in vendor-related systems.
  • Documenting translations status review of the study.
  • Ensuring proper safety information flow with investigative sites.