Clinical Trials Coordinator and Nurse

hace 3 días

Barcelona, Barcelona, España Vhir A tiempo completo

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, coordinating, managing, and promoting patient recruitment, performing data entry, and maintaining up-to-date clinical data.

The ideal candidate will have at least 2 years of experience working in clinical trials, with a strong background in nursing and a Master's degree in Health or Science. Fluency in Catalan, Spanish, and English is required, with training in GCP and experience with SAP management software being highly desirable.

The Clinical Trials Management Unit is responsible for overseeing the operational activities of commercial clinical studies at the Vall d'Hebron Campus, supporting clinicians and Principal Investigators in conducting their clinical studies in accordance with each protocol, while adhering to GCP and current regulations.

This position offers a full-time contract with a gross annual salary that will depend on experience and skills, consistent with our Collective Agreement pay scale.

The ideal candidate will be able to work independently and collaboratively in a team setting, with excellent communication skills and the ability to respond quickly to requests from the team and sponsor.

The main responsibilities and duties of this position include:

  • 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 trainings.
  • Provide support for all tasks related to their area of responsibility as assigned by their Manager.

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