Start-up Specialist, Phase I

The Start-up Specialist, Phase I serves as the primary contact for investigative sites during start-up activities, ensuring the timely collection of essential documents and compliance with regulatory requirements. This role involves coordinating with EC/IRB/Third body/Regulatory Authorities, maintaining awareness of current regulatory standards, and acting as a knowledge resource to mentor colleagues. The specialist is responsible for preparing and reviewing submission documents, tracking site activation milestones, and resolving informed consent issues to ensure study readiness.