Study Coordinator (Clinical Trials Management Unit)

The Commercial and Contracted Clinical Research Directorate at Vall dHebron Institute of Research (VHIR) supports the clinical research community at Vall dHebron Campus throughout the entire lifecycle of commercial clinical trials. This Directorate assists clinical research teams at Vall dHebron 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 dHebron Campus. The primary objective of this Unit is to support clinicians and Principal Investigators at Vall dHebron 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 combining Study Coordinator with other general and specific responsibilities in the field of Clinical Research.

Education and qualifications:

Required:

• Bachelors degree in Life Sciences
• Proficient computer skills (Microsoft Office email)
• Fluency in Catalan Spanish and English (business level)

Desired:

• Training in Good Clinical Practice
• Bachelors degree in Nursing
• Masters degree in Clinical trials

Experience and knowledge:

Required:

• At least 1 year of experience working in hospital environments
• Experience with SAP management software
• Ability to work independently and collaboratively in a multidisciplinary team setting
• Strong communication skills

Desired:

• Previous experience as Study Coordinator and or Study Nurse
• 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:

• Coordinate manage and promote patient recruitment for clinical trials.
• Maintain up-to-date clinical data from source documents to eCRFs CTMS and ISF.
• When appropriately accredited perform nursing tasks including withdrawal and processing of samples related to the clinical trials.
• 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 from clinical source documents.
• Manage Investigational Medicinal Product returned from patients and keep related 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.
• 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:

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 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.