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Clinical Trial Assistant Senior

hace 3 meses


Madrid, España Sermes A tiempo completo

Clinical Trial Assistant SeniorLugar - MadridTipo de Contrato - 6 meses – prórroga de 6 meses - IndefinidoCondiciones económicas - A convenirExperiencia - 5 añosIdiomas - Inglés B2DescripciónSoporte en las gestiones administrativas necesarias para solicitar, hacer seguimiento y recibir resolución final en relación a las aprobaciones/autorizaciones para llevar a cabo la tramitación inicial de un estudio, así como modificaciones sustanciales de Investigación Clínica, de acuerdo a la legislación y/o PNTs aplicables en relación con CEICs, CEIm, AEMPS y CCAA, tales como: seguimiento telefónico, control de calidad de documentos, revisión de los aprobados, solicitud de documentación, generación de tablas de trazabilidad.Actualización del REeC.Preparación del TMF, ISF y archivo de farmacia.Preparación y supervisión de los formularios necesarios para la puesta en marcha del estudio, así como las modificaciones sustanciales y notificaciones.Revisión y adaptación a la legislación aplicable de documentos generales del estudio.Gestión de las tasas de evaluación necesarias (solicitud, seguimiento de factura y gestión de abono).Soporte en la preparación del documento de respuestas a las aclaraciones de CEICs, CEIm, AEMPS y CCAA, así como la adaptación o implementación de cambios solicitados en los documentos esenciales del estudio en coordinación con el equipo del Departamento de Investigación Clínica o Departamento de Calidad y Documentación asignado.Preparación del transmittal form de los CRDs.FormaciónCurso de CTA o experiencia en puesto similar de al menos 5 años.#J-18808-Ljbffr