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 strong 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 - saint-esprit (Saint-Esprit, Quebec)
🏢 ARTO
📍 Saint-Esprit, Quebec