The Clinical Trials Management Unit is responsible for overseeing the operational activities of the commercial clinical studies at the Vall dHebron Campus. The primary objective of this Unit is to support clinicians and Principal Investigator of Vall dHebron 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 dHebron University Hospital have significantly increased contributing to improve life expectancy for our patients. This growth demands a wellorganized odical and peopleoriented individual who is eager to develop a career in this field.
The Clinical Trials Management Unit is seeking to fill a unique positition 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:
- Bachelors Degree in Nursing
- Masters degree in Health or Science
- Fluency in Catalan Spanish English (business level)
Desired:
- Training in GCP (Good Clinical Practice)
- Master in Clinical trials
Experience and knowledge:
Required:
- At least 2 years of experience working in clinical trials focused 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 odical with strong motivation and initiative.
- Excellent communication ss.
- Ability to respond quickly to requests from the team and sponsor.
Main responsibilities and duties:
- Coordinate manage and promote patient recruitment for clinical trial.
- Perform data entry for a phase II III and IV studies.
- Maintain uptodate clinical data from source doents to eCRFs CTMS and ISF.
- Provide support to the clinical team and report to the Clinical Trials Management Unit.
- ist 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 notification process of Adverse Events (AE) and Serious Adverse Events (SAE).
- Coordinate reception and return of equipment provided by the sponsor.
- Prepare required doentation in case of audit or inspection visits.
- Supervise intern trainings
- Provides support for all tasks related to their area of responsibility as igned by their Manager.
Labour conditions:
- Fulltime position: 40h/week.
- Starting date: immediate
- Gross annual salary: Remuneration will depend on experience and ss. Salary ranges are consistent with our Collective Agreement pay scale)
- Contract:Technical and scientific activities contract linked to the project activities
What can we offer
- Incorporation to Vall dHebron Research Institute (VHIR) a public sector institution that promotes and develops the biomedical research innovation and teaching at Vall dHebron 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 highend 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: 17Oct2024
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.