PSI CRO AG is hiring a
Site Management Associate I

Summary

Join our international team as a Clinical Trial Associate (CTA) to support clinical research projects by streamlining communication, maintaining systems, and managing documents & information.

Requirements

• College/University Degree in Life Sciences
• Administrative work experience, preferably in an international settings
• Prior experience working as CTA for CROs
• Prior experience working in Clinical Research
• Local regulations knowledge
• Full working proficiency in English and Spanish
• Proficiency in MS Office applications
• Ability to plan and work in a dynamic team environment
• Communication and collaboration skills

Responsibilities

• Be the main point of contact between site personnel and CRA involved in the project helping on query resolution and EDC completion
• Serve 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
• Assist 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
• Ensure 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
• Ensure proper safety information flow with investigative sites