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 robust 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 Cambridge
🏢 Bilinguallink
📍 Cambridge