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
We are currently seeking a Site Specialist I (Study Start Up Associate I)to join our diverse and dynamic team. As a Site Specialist I at ICON, you will support investigator sites with key administrative and operational activities to help ensure clinical trials run smoothly, efficiently, and in compliance with applicable regulations.
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 and ICH/GCP guidelines.- Support coordination of all necessary translations required for any start-up documentation.- Perform timely and accurate progress data entry of all documents collected from sites and of the relevant study site activation activities into the appropriate tracking systems and tools.- Participate to internal study review meetings with study teams to provide updates on site progress in document collection and on the executed site activation tasks.- Accurately forecast Site Activation plans and ensure that they are reflected accurately in ICON’s systems and proactively follow through for achievement to plan.- Ensure accuracy and timely completen
📌 Study Start Up Associate I (Buenos Aires)
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📍 Buenos Aires
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