Timely, high‑quality site activation readiness for assigned sites and risk mitigation.
Prepare CTA forms and submission dossiers for authorities and ethics committees per ICH‑GCP.
Interact with Competent Authorities/Ethics Committees for submissions and responses.
Provide regular updates on CA/EC submissions to study leads and project team.
Maintain project plans, trackers and regulatory intelligence tools for assigned responsibilities.
Partner with site CRA to ensure aligned communication and secure site activation.

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