Senior Clinical Research Associate

Résumé du poste

The role involves managing site selection and regulatory submissions for an international randomized clinical trial. Key tasks include onboarding sites, preparing submission packages for Ethics Committees, and coordinating document translations.

Détails du poste

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

Ce que vous ferez

The role involves managing site selection and regulatory submissions for an international randomized clinical trial. Key tasks include onboarding sites, preparing submission packages for Ethics Committees, and coordinating document translations.

Exigences

Candidates must be experienced Senior CRAs with a strong understanding of local regulatory frameworks and late-stage study experience. Autonomy and proficiency in site selection and regulatory submissions are essential.

Compétences indiquées

• Soins cliniques · Souhaitée
• preparation · Souhaitée
• Client · Souhaitée
• Communication · Souhaitée
• coordination · Souhaitée
• Onboarding · Souhaitée

Autres compétences pertinentes

Relevées dans la description du poste. Confirmez les exigences importantes ci-dessus.

• Site Selection
• Regulatory Submissions
• Clinical Trial Management
• Informed Consent Preparation
• Regulatory Guidance
• Phase II Studies
• Phase III Studies
• Clinical Research
• Ethics Committee Submissions
• Competent Authority Submissions

Domaines d’emploi

• Healthcare
• Science & Research
• Consulting
• Manufacturing