Clinical Trials Coordinator and Nurse

hace 4 semanas

Barcelona, Barcelona, España Vhir A tiempo completo
Job Description

The Clinical Trials Management Unit at Vhir is seeking a highly organized and methodical individual to fill a unique position that combines the roles of Study Coordinator and Study Nurse. This individual will focus on clinical trials within the Immunomediated Diseases and Global Health areas.

Responsibilities
  • Coordinate, manage, and promote patient recruitment for clinical trials.
  • Perform data entry for phase II, III, and IV studies.
  • Maintain up-to-date clinical data from source documents to eCRFs, CTMS, and ISF.
  • Provide support to the clinical team and report to the Clinical Trials Management Unit.
  • Assist the research team with tasks essential to study development.
  • Attend site monitoring visits, review, and resolve queries in accordance with GCP.
  • Withdraw and process samples.
  • Manage Investigational Medical Product (IMP) returned from patients and keep related accountability and adherence information up to date.
  • Support in the notification process of Adverse Events (AE) and Serious Adverse Events (SAE).
  • Coordinate reception and return of equipment provided by the sponsor.
  • Prepare required documentation in case of audit or inspection visits.
  • Supervise intern training.
  • Provide support for all tasks related to their area of responsibility as assigned by their Manager.
Requirements
  • Bachelor's Degree in Nursing.
  • Master's degree in Health or Science.
  • Fluency in Catalan, Spanish, and English (business level).
  • At least 2 years of experience working in clinical trials focused on Immunomediate and Global Health areas.
  • At least 3 years of experience working in hospital environments.
  • Ability to work independently and collaboratively in a team setting.
  • Experience with SAP management software.
Desired
  • Highly organized and methodical, with strong motivation and initiative.
  • Excellent communication skills.
  • Ability to respond quickly to requests from the team and sponsor.

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