Site Management Associate I

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.