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 Investigator of Vall d'Hebron Campus in conducting their clinical studies in accordance with each protocol, while adhering GCP and current regulations.
Over the past year, the number and complexity of clinical trials at Vall d'Hebron University Hospital has significantly increased, contributing to improve 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 a Study Nurse.
This vacancy will focus on clinical trials within the Immunomediated Diseases, Global Health and Paediatrics area of knowledge.
Education and qualifications: Required: Bachelor's Degree in Nursing Fluency in Catalan, Spanish, English (business level) Desired: Training in GCP (Good Clinical Practice) Master's degree in Health or Science Master in Clinical trials Experience and knowledge: Required: At least 2 years of experience working in hospital environments.
Ability to work independently and collaboratively in a team setting.
Experience with SAP.
Desired: At least 2 years of experience working in clinical trials.
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: Ensure patient safety and ethical compliance through the clinical trial process.
Apply Good Clinical Practice (GCP) guidelines and, when managing samples, adhere to IATA standards and relevant Standards Operating Procedures (SOPs) when managing biological samples (withdraw, processing, aliquoting and shipping).
Monitor and document patient involvement in clinical studies according to study protocols, including relevant procedures such as blood sample collection, electrocardiograms, vital signs monitoring, and spirometry or other procedures in which might be delegated.
Administer or oversee the administration of investigational medications (intravenous, intramuscular, subcutaneous, or oral) as delegated by the Principal Investigator, ensuring compliance with protocol requirements.
Support coordination activities for clinical trials as needed, under the directions of the principal investigator.
Collaborate with multidisciplinary teams to facilitate effective communication and coordination of care within the clinical trial context.
Assist in data collection and management, ensuring accuracy and integrity of data reported during the clinical trial.
Participate in training and education sessions for study staff and patients regarding clinical trial protocols and procedures.
Maintain up-to-date clinical data from source documents to eCRFs, CTMS and ISF.
Attend site monitoring visits, review and resolve queries in accordance with GCP.
Manage Investigational Medical Product (IMP) returned from patients and keep related accountability and adherence information up to date.
Support in notification process of Adverse Events (AE) and Serious Adverse Events (SAE).
Prepare required documentation in case of audit or inspection visits.
Provides 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.
2 available positions.
What can we offer?
Incorporation to Vall d'Hebron Research Institute (VHIR), a public sector institution that promotes and develops the biomedical research, innovation and teaching at Vall d'Hebron University Hospital (HUVH), the biggest hospital of Barcelona and the largest of Catalan Institute of Health (ICS).
A scientific environment of excellence, highly dynamic, where high-end biomedical projects are continuously developed.
Continuous learning and a wide range of responsibilities within a stimulating work environment.
Individual training opportunities.
Flexible working hours.
23 days of holidays + 9 personal days.
Flexible Remuneration Program (including dining checks, health insurance, transportation and more) Corporate Benefits: platform through which you can obtain significant discounts on travel, culture, technology, gastronomy, sports... among many others.
Healthy Offering: choose from a variety of wellbeing focused activities to be the healthiest you.
Deadline to apply: 19-11-2024 VHIR embraces Equality and Diversity.
As reflected in our values we work toward ensuring inclusion and equal opportunity in recruitment, hiring, training, and management for all staff within the organization, regardless of gender, civil status, family status, sexual orientation, gender identity and expression, religion, age, functional diversity or ethnicity.
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