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 in office 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 robust 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
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📌 Senior Clinical Research Associate Saguenay
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📍 Saguenay