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CRA II (Multisponsor) - Hybrid Madrid or Barcelona

syneoshealth · ESP-Madrid-Hybrid

Nuevo
Hybrid Mid 🇬🇧 English
ICH-GCP Source document review Chart abstraction

Descripcion del puesto

About the role

Syneos Health is hiring a CRA II (multisponsor) for a hybrid position in Madrid or Barcelona. The role covers site qualification, initiation, interim monitoring, site management and close-out visits, performed on-site or remotely, in line with regulatory, ICH-GCP and protocol requirements.

Key responsibilities

  • Evaluate site and site staff performance, escalate serious issues and develop action plans
  • Verify informed consent, protect subject confidentiality and assess safety and data integrity risks
  • Review source documents and CRFs, resolve queries and verify electronic data capture compliance
  • Check investigational product inventory, dispensing, labelling and release, and reconcile the Investigator Site File with the Trial Master File
  • Document activities, support recruitment and retention, and prepare sites for audits
  • Attend investigator meetings, project meetings and clinical training, and suggest potential sites
  • For Real World Late Phase studies: site support throughout the lifecycle, chart abstraction, data collection and collaboration with sponsor affiliates and medical science liaisons

Required profile

  • Bachelor's degree or RN in a related field, or equivalent education, training and experience
  • At least 1 year of independent on-site monitoring
  • Good computer skills and ability to adapt to new technologies
  • Excellent communication, presentation and interpersonal skills
  • Willingness to travel regularly up to 75%

Questions fréquentes

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Source : ats:workday

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Publicado hace 7 horas

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syneoshealth

ESP-Madrid-Hybrid