About this role
The Academic and Commercial Clinical Research Directorate at Vall d’Hebron Institute of Research supports the clinical research community at Vall d’Hebron Campus throughout the entire lifecycle of commercial clinical trials. It assists clinical research teams at Vall d’Hebron University Hospital participating in clinical trials. The Clinical Trials Management Unit oversees operational activities of clinical studies.
The unit supports clinicians and Principal Investigators in conducting studies per protocol, Good Clinical Practice, and regulations. As Study Coordinator, coordinate patient recruitment, maintain clinical data in eCRFs, CTMS, and ISF. Perform data entry for phase I-IV studies and manage Investigational Medicinal Product accountability.
Support Adverse Events notifications, attend monitoring visits, resolve queries per GCP, and handle sponsor equipment. Prepare documentation for audits or inspections. Provide support to the clinical team and report to the Clinical Trials Management Unit.
Join a multidisciplinary team in a hospital research environment as a well-organized, methodical, people-oriented individual. This unique role combines Study Coordinator duties with general responsibilities in Commercial and Contracted Clinical Research. Gain pathology-specific knowledge for accurate protocol understanding and data extraction.
Requirements
- Experience working in a research and/or hospital environment
- Ability to work independently and collaboratively in a multidisciplinary team setting
- Strong communication skills
- Previous experience as Study Coordinator (desirable)
- Knowledge of e-CRF and management of clinical data related to clinical trials (desirable)
- Experience with SAP management software (desirable)
- Highly organised and methodical, with strong motivation and initiative (desirable)
- Ability to promptly and effectively respond to requests from both the team and the sponsor (desirable)
Responsibilities
- Coordinate, manage, and promote patient recruitment for clinical trials
- Maintain up-to-date clinical data from source documents to eCRFs, CTMS, and ISF
- Perform data entry for phase I, II, III, and IV studies
- Acquire pathology-specific knowledge to ensure accurate understanding of the protocol and data extraction
- Manage Investigational Medicinal Product returned from patients and keep accountability and adherence information up to date
- Support the notification process of Adverse Events and Serious Adverse Events
- Attend site monitoring visits, review, and resolve queries in accordance with GCP
- Prepare required documentation in case of audit or inspection visits
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