Job Description

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.

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Scope of the mission

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- Site selection (including on-site visits if required)
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- Support to site onboarding and informed consent preparation
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- Package preparation for Regulatory submissions (Ethics Committees / Competent Authorities)
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- Adaptation of documents to local requirements and translation coordination
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- Country-specific regulatory guidance
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Profile requirements

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- Senior CRA with solid autonomy
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- Experience in site selection and submissions
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- Knowledge of local regulatory requirements
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- Late-stage study experience (phase II, III)
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- Solid understanding of country-specific regulatory frameworks
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- Local language may be required depending on country
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📌 Senior Clinical Research Associate (New South Wales)
🏢 ARTO
📍 New South Wales