Study Start Up Associate II

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.

Responsibilities

• Proficient knowledge of ICON SOPs/WPs, ICH/GCP and applicable country regulations/guidelines and ICON systems.
• Support Site Partners to collect, review, organize and assemble initial start-up and maintenance submission packages to Central EC/IRB, Local EC/IRB, Competent Authorities, any other local regulatory authorities as required by countries and in accordance with ICH/GCP and applicable country regulations/guidelines.
• Support collection and assembling of all documents needed in the Critical Document Package (CDP) and/or those required for site activation, ensuring that Sponsor and Investigator obligations are being met and are in compliance with applicable requirements a...