Clinical research associate

hace 3 días


Madrid, España Hays A tiempo completo

Desde Hays estamos buscando incorporar un/a Clinical Research Associate (CRA) Freelance para participar en un proyecto estratégico dentro del sector farmacéutico, trabajando con un equipo internacional y en estudios clínicos de Fase III. ¿Qué harás?Monitorizar ensayos clínicos Fase III de forma presencial y remota. Gestionar y realizar el seguimiento de centros asignados en la zona correspondiente. Verificar el cumplimiento de: ICH-GCP Reglamento Europeo de Ensayos Clínicos (EU 536/2014) Normativa española (AEMPS, CEIm) Revisar documentación esencial: e CRF vs historia clínica (SDV / SDR) Consentimientos informados Seguridad y reporte de SAEs Asegurar la correcta gestión del medicamento en investigación (IMP). Formar y apoyar a investigadores y personal de los centros. Coordinarte con Project Managers, Clinical Leads, Data Management y QA. Elaborar informes de visitas de inicio, seguimiento y cierre. Detectar y dar seguimiento a desviaciones, CAPAs y riesgos del estudio.RequisitosFormación universitaria en Ciencias de la Salud (Farmacia, Biología, Biotecnología, Medicina, etc.). Experiencia sólida como CRA (5+ años). Experiencia demostrable en ensayos clínicos Fase III (imprescindible). Conocimiento sólido de normativa europea y española de investigación clínica. Dominio de ICH-GCP y regulación nacional/internacional. Capacidad de organización, autonomía y atención al detalle. Habilidades de comunicación y trabajo en equipo. Inglés medio-alto (entorno internacional).¿Qué ofrecemos?Modalidad Freelance Ubicación: Zona norte de España. Proyecto estable, internacional y con alto impacto en investigación clínica.Estamos buscando perfiles apasionados por la investigación clínica, el cumplimiento regulatorio y la excelencia operativa en estudios avanzados. Si es tu caso, inscríbete en la oferta para que podamos contarte más.



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