The client is preparing the launch of an international randomized clinical trial (RCT) across Europe Canada, and the United States to support marketing authorization. Due to the absence of a full CRO model, key activities will be managed internally. We are therefore seeking experienced Senior CRAs to support site selection and regulatory submissions.

Scope of the mission - Site selection (including on-site visits if required) - Support to site onboarding and informed consent preparation - Package preparation for Regulatory submissions (Ethics Committees / Competent Authorities) - Adaptation of documents to local requirements and translation coordination - Country-specific regulatory guidance Profile requirements - Senior CRA with solid autonomy - Experience in site selection and submissions - Knowledge of local regulatory requirements - Late-stage study experience (phase II, III) - Solid understanding of country-specific regulatory frameworks - Local language may be required depending on country

📌 Senior Clinical Research Associate (Canada)
🏢 ARTO
📍 Canada