Site Start Up Specialist

Job description

Study Start Up Specialist ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development As a Study Start Up Associate II at ICON, you will lead the initiation of clinical trials, ensuring compliance with regulatory requirements, and contribute to the advancement of innovative treatments and therapies. What You Will Do: You will contribute to site start-up and activation activities, taking responsibility for your deliverables and working collaboratively. Key responsibilities include: - Leading the preparation and submission of regulatory documents, including clinical trial applications, ethics committee submissions, and regulatory agency communications. - Coordinating and liaising with internal and external stakeholders to obtain necessary approvals and authorizations for study initiation. - Managing and maintaining comprehensive and accurate records of regulatory submissions, approvals, and correspondence - Providing guidance and support to study teams on regulatory requirements and best...