Responsible for the delivery of site activation readiness and mitigating any risks. Preparation of Clinical Trial Application Forms and submission dossier for submission to Competent Authorities, Ethics Committees, and other applicable local bodies according to requirements. Interaction with CA/EC for study purposes and handling responses to the CA/EC. Maintenance of project plans, project trackers and regulatory intelligence tools. Partner with the assigned site CRA to ensure alignment in communication and secure site review and manage collection of essential documents required for site activation/IMP release.
Job listings
$85,000–$115,000
USD/year
The Regulatory and Start Up Specialist (RSS) is an experienced professional in regulatory and site start-up activities, responsible for delivery, in terms of timeliness and quality, of site activation readiness within the assigned country/sites, and mitigating any risks.