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El CE apoyará, facilitará y coordinará las actividades diarias de investigación clínica del/de los estudio(s) y desempeñará un papel fundamental en la ejecución del estudio. El CE trabajará estrechamente con el IP, el Centro Coordinador de LaRed (LaRed\\-CC), otros sitio(s) participante(s), patrocinador(es) y otras entidades relacionadas con el estudio clínico.\n\n**FUNCIONES:** El Coordinador de Estudios es responsable de las actividades relativas al protocolo de LaRed en un sitio asignado. Aunque la seguridad y el bienestar del participante del estudio son, en última instancia, responsabilidad del IP, el CE debe trabajar estrechamente con el IP del centro para garantizar el bienestar de los sujetos. 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Colaborar con el Centro Coordinador de LaRed (LaRed\\-CC) según sea necesario para preparar y presentar dichos documentos con éxito.\n* Mantener los registros requeridos de la actividad del estudio, incluidos, entre otros: formularios de registro de casos, registros de dispensación de medicamentos o cualquier otro formulario reglamentario considerado pertinente.\n* Apoyar las visitas de inicio del sitio y las visitas intermedias de supervisión según sea necesario:\n\t+ Trabajar con los investigadores del sitio, otros miembros del personal y el LaRed\\-CC para cumplir con los requisitos de inicio, implementación y cierre del estudio.\n\t+ Seguimiento del progreso del sitio conforme a los requisitos de activación, intermedios y de cierre del sitio.\n\t+ Resolver todos los problemas de forma oportuna, incluidas las desviaciones respecto al protocolo/reglamentarias y las discrepancias en los datos identificadas durante las visitas de supervisión.\n\t+ Asistir en la corrección de cualquier hallazgo negativo de forma oportuna, según sea necesario.\n\t+ Notificar todos los eventos adversos (EA) y problemas inesperados (PI) al IP del sitio; coordinar la notificación de EA y PI al LaRed\\-CC, al patrocinador del estudio, al Comité de Ética correspondiente y a cualquier otra agencia reglamentaria, en cumplimiento de las BPC, las normativas internacionales y nacionales, el protocolo del estudio y los procedimientos de LaRed.\n* Coordinar las operaciones de los estudios de investigación:\n\t+ Obtener el consentimiento informado apropiado con la documentación correspondiente del sujeto del estudio o de su tutor legal.\n\t+ Seleccionar, reclutar y retener a los sujetos del estudio.\n\t+ Programar las visitas de los sujetos y las actividades clínicas relacionadas según el protocolo.\n\t+ Seguimiento de los sujetos según lo requiera el protocolo.\n\t+ Implementar los procedimientos del estudio según la capacidad clínica y la formación recibida.\n\t+ Garantizar la recolección, el procesamiento y el envío adecuado de muestras biológicas.\n\t+ Contactar al laboratorio, al IP del sitio y al patrocinador respecto a problemas o incidencias en el laboratorio, según sea necesario.\n\t+ Recopilar y archivar los resultados del laboratorio, según sea necesario.\n\t+ Recopilar los datos de los participantes en los documentos fuente, según sea necesario.\n\t+ Garantizar la extracción exhaustiva y precisa de los datos de los documentos fuente en los Formularios de Registro de Casos (FRC) o en los Formularios Electrónicos de Registro de Casos (FREC).\n\t+ Garantizar que la recopilación de datos, la introducción de datos, las consultas sobre datos y las discrepancias se completen y aborden de forma oportuna.\n\t+ Desarrollar y mantener actualizados los POE y otros documentos procedimentales específicos del sitio asignado, según sea necesario.\n\t+ Garantizar la exactitud de las prácticas clínicas en las actividades del protocolo.\n\t+ Evaluar la seguridad del sujeto durante toda su participación en el estudio y supervisar a los sujetos respecto a EA y PI según corresponda.\n\t+ Comunicar al IP cualquier preocupación relacionada con los derechos, la privacidad o el bienestar del sujeto tan pronto como surjan dichas preocupaciones.\n\t+ Consultar con el IP sobre dudas acerca de la interpretación del protocolo, de cualquier documento relacionado, de los documentos fuente de los sujetos y del FRC/FREC.\n* Facilitar y coordinar la logística de los suministros y equipos específicos del sitio y del estudio asignados al sitio, en colaboración con el IP y el LaRed\\-CC:\n\t+ Coordinar la contabilidad financiera y la facturación de los suministros del estudio.\n\t+ Identificar y documentar los artículos que requieren aportación o autorización por parte de la institución anfitriona del sitio.\n\t+ Garantizar que se realicen correctamente la documentación y las autorizaciones correspondientes para los activos aportados/financiados por el patrocinador estadounidense, en colaboración con el LaRed\\-CC, quien coordina la logística de adquisición de dichos artículos. Dichos activos pueden incluir, aunque no se limitan a: congeladores, centrífugas, otros equipos de laboratorio, computadoras, impresoras, pruebas rápidas de influenza, pruebas de embarazo y diversos insumos para muestreo.\n* Mantener una comunicación abierta con todo el personal del sitio y con los colaboradores de LaRed, incluidos:\n\t+ El IP del sitio y\n\t+ El LaRed\\-CC\n\t+ El personal de apoyo del estudio, p. ej., administradores/gestores de datos, laboratorios y farmacias.\n* Participar en cualquier teleconferencia o reunión web de LaRed relevante o asignada según sea necesario, p. ej., llamadas específicas del estudio con los sitios y seminarios web de actualización formativa.\n* Coordinar la preparación para auditorías del sitio y los esfuerzos de mejora de la calidad:\n\t+ Colaborar con el IP, otros miembros del personal del sitio y el LaRed\\-CC para diseñar e implementar objetivos y planes de gestión de la calidad para los estudios.\n\n\nCuando el sitio asignado no tiene un 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