Site Specialist II - Hybrid Mexico City
ICON is a general healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.
As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.
- Location: Mexico City (only)
- Hybrid model (3 days in the office – 2 days working from home
As a Site Specialist II you will support preparation, process and tracking of regulatory and site level critical documents and of site activation tasks required for study site activation in accordance with ICON SOPs/WPs, Sponsor SOPs, applicable regulations/guidelines and the principles of ICH/GCP.
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
📌 Site Specialist II (Ciudad de México)
🏢 IRE
📍 Ciudad de México
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