Clinical Trial Assistant Senior

hace 2 semanas


Madrid, Madrid, España Sermes Cro A tiempo completo
Clinical Trial Assistant SeniorLugar
  • MadridTipo de Contrato 6 meses prórroga de 6 meses
  • IndefinidoCondiciones económicas
  • A convenirExperiencia 5 añosIdiomas
  • Inglés B2Soporte 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 trazabilidadActualización del REeCPreparación del TMF, ISF y archivo de farmaciaPreparación y supervisión de los formularios necesarios para la puesta en marcha del estudio, así como las modificaciones sustanciales y notificaciones (Formulario de Solicitud Anexo 1 A (Xml), Formulario Modificación Sustancial, Formulario 1D, etc.)
Revisión y adaptación a la legislación aplicable de documentos generales del estudioGestión 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 (ej.
HIP, cuestionarios, tarjeta de paciente) en coordinación con el equipo del Departamento de Investigación Clínica o Departamento de Calidad y Documentación asignado.
Preparación del transmittal form de los CRDsCurso de CTA o experiencia en puesto similar de al menos 5 años#J-18808-Ljbffr
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