Senior Clinical Research Associate – ARTO

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 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