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Open nowFirst seen 5 days ago

Enfermero/a de Ensayos Clinicos

Triskel Consulting23 open roles

Where
Santiago de Compostela, Municipality of Santiago de Compostela, Spain
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Your applicationOpen nowEnfermero/a de Ensayos ClinicosTriskel Consulting · Santiago de Compostela, Municipality of Santiago de Compostela, Spain

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The clock on this job

Early applications get read.

12.3% of postings close within 7 days. Measured by our own scanner across the market. Triskel Consulting postings stay open a median of 1 days.

Share of postings closed within
  1. 2.1%1 day
  2. 4.5%3 days
  3. 12.3%7 days
  4. 19.3%14 days
  5. 35.6%30 days
  6. 58.1%60 days
This job: first seen 5 days ago

Triskel Consulting median: 1 days open

The posting

Empresa de renombre en el sector de la investigación busca Enfermero/a para Ensayos Clinicos. La persona seleccionada desarrollará sus funciones bajo la supervisión funcional del/de la líder de grupo y la Dirección del centro, con quienes colaborará activamente para garantizar el correcto desarrollo de las tareas asignadas.

Responsabilidades:

  • Actuar como nexo de comunicación entre el promotor del ensayo y el centro (equipo investigador y servicios implicados).
  • Participar activamente en las visitas de inicio, monitorización y cierre de estudios, así como en auditorías.
  • Elaborar Procedimientos Normalizados de Trabajo (PNTs) y hojas de enfermería tras la visita de inicio. Impartir formaciones específicas del estudio al personal implicado.
  • Crear y mantener actualizada la carpeta de documentación de cada estudio. Subir y gestionar los documentos esenciales.
  • Identificar pacientes potenciales para el reclutamiento y dar soporte al equipo médico en el cumplimiento de las Buenas Prácticas Clínicas (BPC).
  • Supervisar la correcta cumplimentación del consentimiento informado por parte de los pacientes.
  • Elaborar y actualizar las bases de datos y tablas de seguimiento de pacientes por estudio.
  • Gestionar la programación de visitas de pacientes en la plataforma IANUS, así como la planificación de los procedimientos y pruebas requeridas.
  • Solicitar, coordinar y enviar pruebas de imagen (TAC, RMN, GGO, MUGA, etc.) al promotor del estudio.
  • Registrar y aleatorizar pacientes en sistemas IWRS y completar el Cuaderno de Recogida de Datos (CRF).
  • Realizar extracciones de muestras biológicas y gestionar los kits del estudio.
  • Procesar, almacenar y enviar muestras (tumorales, sanguíneas, urinarias, etc.) según los protocolos establecidos.
  • Realizar la toma de constantes vitales, electrocardiogramas (ECG) y cuestionarios de calidad de vida.
  • Administrar medicación intravenosa, tanto comercial como en investigación, conforme a los protocolos de ensayo.
  • Registrar y actualizar los datos clínicos del paciente en el CRF dentro de los plazos establecidos, así como resolver discrepancias (queries).
  • Notificar y realizar el seguimiento de Acontecimientos Adversos (AE, SAE y AESI) dentro de los plazos indicados por el promotor.
  • Gestionar el reembolso de gastos derivados de la participación del paciente (transporte, manutención...).
  • Colaborar en la gestión documental de los ensayos clínicos: calibraciones, mantenimientos, registros, incidencias y acciones correctivas/mejoras dentro del sistema de calidad.

Requisitos del puesto

  • Diplomatura o Grado en Enfermería (titulación acreditada mediante copia compulsada).
  • Experiencia profesional previa en enfermería.
  • Experiencia específica en el área de oncología.
  • Experiencia demostrable en ensayos clínicos y proyectos de investigación.
  • Conocimientos sólidos de Buenas Prácticas Clínicas (BPC).
  • Nivel de inglés adecuado para el desempeño de funciones técnicas y comunicativas.
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