Services of the Unit
The services provided by the Unit are currently distributed according to the duties and responsibilities of each of its members.
Head of the Unit
- Directly responsible for the unit and offering consultancy services to researchers on ethical requirements, regulators and contract negotiation.
- She is the contact person for the hospital, the foundation, the sponsors and the CROs.
- Responsible for strategic research projects.
Management and quality coordinator of the Unit
- Responsible for the Unit's management team (start-ups, contracts, invoicing, administration and data entries).
- Responsible for the management of the Unit's non-commercial projects and supervisor of all aspects of quality and training.
- Responsible for establishing general lines of communication with the hospital during clinical trials and other research projects.
Administration and financial management coordinator
- Requests for and preparation of documentation for the processing of contracts with sponsors.
- Invoicing to sponsors and general financial tracking of the Clinical Research Unit.
- Hire and payment of services (CROs, policies).
Manager for the implementation of commercial and academic studies
- Project feasibility analyses with the research teams.
- Management of regulatory documentation.
- Finance impact studies and analysis of internal circuits.
- Analysis of circuits and technical needs of each clinical trial during implementation.
- Support for research teams and services involved in clinical trials.
Nursing coordinator of the Unit
- Responsible for the management of the nursing team of the Unit.
- Contact person with the nursing management team at the hospital.
- Analysis of circuits, technical needs, spaces and HR in each clinical trial.
- Consultant to the Management Unit on nursing procedures in the protocols.
- Supervisor for compliance with good clinical practices.
Research Nurses / Study Coordinators
A nurse is appointed coordinator of each clinical trial at the Sant Joan de Déu Barcelona Children's Hospital. Her main duties and responsibilities are:
- Care and laboratory
- Data management
This person is responsible for liaising between the Clinical Trials Unit, the researcher and the sponsor. This role is assumed by nurses in the Research Unit as delegated by the principal investigator.
This position includes the following duties and responsibilities:
- Facilitate communication within the research team and with external stakeholders.
- Coordinate referrals to other services involved outside the research team.
- Facilitate the programming and coordination of study procedures.
- Coordinate patient visits according to the protocol.
- Comply with good clinical practice and applicable local standards.
- Protect participant data in accordance with regulatory requirements.
- Participate in follow-up visits and audits/inspections.
- Facilitate the processing and handling (storage and transport) of research samples.
- Supervise resources and study-related materials.
- Coordinate team meetings and activities in the context of the study.
- Coordinate research activities to minimize risks to the patients under study.
- Provide direct nursing care for research participants (including administration of treatment during research, sample collection, etc.).
- Communicate study procedures to trial participants.
- Supervise the patients on the clinical trial and report possible adverse events to the researchers.
- Help research participants with consultations.
- Help participants with the process of informed consent and recruitment led by the researchers.
- Register data in the data logbook, resolution of discrepancies and follow-up.
- The research coordinators are supported by data management staff in the register of data in the data logbook, resolution of discrepancies and control of follow-up.