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 solid 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 Sydney
🏢 ARTO
📍 Sydney