The client is preparing the launch of an international randomized clinical trial (RCT) across Europe 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

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📌 Senior Clinical Research Associate (New South Wales)
🏢 ARTO
📍 New South Wales