Clinical Trial Assistant

hace 3 semanas


Madrid, España ALPHA BIORESEARCH A tiempo completo

En Alpha Bioresearch sabemos que el mayor activo de la compañía son las personas, es por ello que nos preocupamos por fomentar su desarrollo tanto profesional como personal ofreciendo la posibilidad de promoción interna así como flexibilidad laboral. Estamos en constante búsqueda de los mejores profesionales, gente preparada con ganas de comerse el mundo. ¿Quieres formar parte de esta pequeña gran familia?

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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