Site Management Associate I

Overview

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

Responsibilities

• Be the main point of contact between site personnel and CRA involved in the project, assisting with query resolution and EDC completion.
• Serve as the primary site contact 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.
• Assist Monitors in the prompt completion of all subject event and site event information in CTMS.
• Track the resolution status of site issues and action items in CTMS.
• Ensure the order, receipt, inventory storage, distribution, return/recall and reconciliation of clinical supplies.
• Ensure regulatory and ethics committee submissions and notifications are up to date with local regulations and dispositions.
• Coordinate preparation for and follow-up on site, TMF and systems audits and inspections.
• Manage the TMF at site and country levels on a regular basis and file documents; prepare, distribute, and update Investigator Site Files (ISF) and ISF checklists.
• Arrange and track initial and ongoing project training for site teams in all vendor-related systems.
• Document management and translations status review of the study.
• Ensure proper safety information flow with investigative sites.

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