Senior Clinical Research Associate
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- 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
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