Clinical Trial Assistant
hace 2 semanas
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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