The Clinical Trials Management Unit is responsible for overseeing the operational activities of the commercial clinical studies at the Vall d'Hebron Campus. The primary objective of this Unit is to support clinicians and Principal Investigators of Vall d'Hebron Campus in conducting their clinical studies in accordance with each protocol, while adhering to GCP and current regulations. Over the past year, the number and complexity of clinical trials at Vall d'Hebron University Hospital have significantly increased, contributing to improved life expectancy for our patients. This growth demands a well-organized, methodical, and people-oriented individual who is eager to develop a career in this field.The Clinical Trials Management Unit is seeking 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.Education and Qualifications:Required:Bachelor's Degree in NursingMaster's degree in Health or ScienceFluency in Catalan, Spanish, and English (business level)Desired:Training in GCP (Good Clinical Practice)Master in Clinical TrialsExperience and Knowledge:Required: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.Main Responsibilities and Duties: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 the 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.Labour Conditions:Full-time position: 40h/week.Starting date: immediate.Gross annual salary: Remuneration will depend on experience and skills. Salary ranges are consistent with our Collective Agreement pay scale.Contract: Technical and scientific activities contract linked to the project activities.
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