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Data Entry
hace 1 hora
The Commercial and Contracted Clinical Research Directorate at Vall d'Hebron Institute of Research (VHIR) supports the clinical research community at Vall d'Hebron Campus throughout the entire lifecycle of commercial clinical trials. This Directorate assists clinical research teams at Vall d'Hebron University Hospital (HUVH) participating in clinical trials and provides support to companies interested in initiating clinical trials at HUVH.
As part of this directorate, 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 at Vall d'Hebron Campus in conducting their clinical studies in accordance with each study protocol, while adhering to Good Clinical Practice and current regulations.
We are currently looking for a well-organized, methodical, and people-oriented individual to join the team as a unique role of Data Entry responsibilities.
Education and qualifications:
Required:
- FP II in Healthcare Documentation and Administration.
- Computer user level (Office package, mail).
- Fluency in Catalan, Spanish, English (business level).
Desired:
- Bachelor's Degree in Health Sciences (preferable but not limited)
- Training in Good Clinical Practice.
- Master´s degree in Clinical trials.
*Experience and knowledge:
Required:*
- Experience working in a research and/or hospital environment.
- Knowledge of database programs.
- Ability to work independently and collaboratively in a multidisciplinary team setting.
- Strong communication skills.
Desired:
- Previous experience as Data entry.
- Experience with SAP management program.
- Knowledge of e-CRF and management of clinical data related to clinical trials.
- Highly organized and methodical, with strong motivation and initiative.
- Ability to promptly and effectively respond to requests from both the team and the sponsor.
*Main responsibilities and duties:*
- Enter and regularly update clinical trial data in software platforms such as CTMS, e-CRF, and others, ensuring accuracy and completeness.
- Contribute to the resolution of data-related queries and discrepancies in collaboration with the clinical team and sponsors.
- Maintain the Investigator Site File and ensure proper filing of correspondence with sponsors and CROs.
- Acquire pathology-specific knowledge to ensure accurate understanding of the protocol and data extraction from clinical source documents.
- Acquire and apply Good Clinical Practice (GCP) standards and relevant Standard Operating Procedures (SOPs).
- Attend site monitoring visits, review, and resolve queries in accordance with GCP.
- Support the notification process of Adverse Events and Serious Adverse Events.
- Manage Investigational Medicinal Product returned from patients and keep related accountability and adherence information up to date.
- Coordinate the reception and return of equipment provided by the sponsor.
- Prepare required documentation in case of audit or inspection visits.
- Provide oversight of intern training and mentorship.
- Provide support to the clinical team and report to the Clinical Trials Management Unit.
- Provide support for all tasks related to the Commercial and Contracted Clinical Research Directorate as assigned by the Manager.
Labour conditions:
- Full-time position
- Starting date: immediate.
- Gross annual salary: Remuneration will depend on experience and skills. Salary ranges are consistent with our Collective Agreement pay scale.
- Contract: Open-ended contract linked to the project.
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:
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.*
