Clinical Trial Assistant

hace 4 semanas


Madrid, España ALPHA BIORESEARCH A tiempo completo

Responsable de las actividades regulatorias de puesta en marcha, seguimiento y cierre de los estudios de Alpha Bioresearch asignados. Cumpliendo los parámetros de calidad requeridos.

Recabar la información de los requerimientos para obtener las aprobaciones de IRB / EC, y la documentación de seguimiento posterior y proporcionar actualizaciones al portal Regulatorio.

Ser la persona de contacto de los centros del proyecto con respecto a la recopilación de documentos esenciales y gestionar las presentaciones de Comités de ética y Agencias Regulatorias.

Tramitación de los contratos entre Promotor de un proyecto de investigación y el centro y/o fundación.

Creación y mantenimiento de los archivos del proyecto: archivo maestro del estudio (Trial Master File) y archivo del investigador (investigator site file).

Gestión del envío de material de los proyectos.

**Requisitos**:
Al menos 1 AÑO como CTA en una CRO o en la industria farmacéutica.

Gran capacidad de trabajo en equipo

Gran capacidad de comunicación e interacción con otros equipos.

Conocimiento de las guías ICH-GCP y legislación local e internacional en materia de investigación clínica.

Conocimiento de Informática a nível de usuario: Word, Excel, Outlook, PowerPoint, Internet Explorer.

Nível alto de inglés hablado y escrito (valorable Portugués).

**CONDICIONES**

INCORPORACIÓN: Inmediata.

REMUNERACIÓN: Según experiência



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