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 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