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Site Management Associate I

hace 2 meses

Santiago, Chile Psicro A tiempo completo

Join our international team and be the key support to clinical research projects, streamlining communication, maintaining systems and managing documents & information.

Only CVs in English will be accepted.

You will be responsible for:
  • Being the main point of contact between site personnel and CRA involved in the project helping on query resolution and EDC completion.
  • Serves as the primary sites’ contact point for vendors, study supplies, and access management.
  • Ensure that pre-study testing (scans, MRI/CT qualification questionnaires, test ECGs, etc.) of local site facilities is completed.
  • Assists the Monitors in their prompt completion of all subject event and site event information in CTMS. Track the resolution status of site issues and action items in CTMS.
  • Act as the one who will ensure the order, receipt, inventory storage, distribution, return/recall and reconciliation of clinical supplies.
  • Ensures regulatory and ethics committee submissions and notifications, meaning you will need to be up to date on local regulations and dispositions.
  • Coordinate preparation for and follow-up on site, TMF and systems’ audits and inspections.
  • Manage the TMF on a site and a country level for regularly and file documents. Prepare, distribute, and update Investigator Site Files (ISF) and ISF checklists.
  • Arrange and track initial and on-going project training for site teams in all vendor-related systems.
  • Document management and translations status review of the study.
  • Ensures proper safety information flow with investigative sites.
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