Description
The Clinical Trials Regulatory Specialist serves as the primary contact for investigative sites during study start-up and maintenance, collects and reviews regulatory and investigator documents, prepares and submits IND/CTA and other regulatory submissions, coordinates with EC/IRB/Third-body and regulatory authorities, and supports site activation, informed-consent compliance, CTIS monitoring, and project timelines. The role requires a life-science or allied-health degree or certification, or an alternative high-school-plus-clinical-research pathway, along with at least two years of clinical development or start-up/regulatory experience and knowledge of ICH, RA, and IRB/IEC regulations.
