Regulatory specialist - Cancer Clinical Trials - Replacement Position

Reference: 23-183_SS_VN

About the research group

Breast cancer

ICO-L’Hospitalet is a reference hospital for the clinical research in cancer. Their two units (UIC and UFF1) have been participating in 506 clinical trials with active recruitment or with current activities during 2021 and 747 patients decided to participate in them. Many of these trials are testing the most promising therapies in cancer and investigators involved in them are specialized and up-to-date with the latest advances in new treatments. UIC and UFF1 units have the best professionals who carry out the most demanding clinical trials.

About the role

Specialist in clinical trial’s administrative management. The selected candidate will be in charge of actions regarding to the application of documentation according to clinical trial’s regulation in between three parties: site investigator’s team and delegated personnel, site management team and sponsors or CROs. Regulatory specialist will be involved in all trial stages: the proposal; approval of independent review boards and Spanish and European agencies; the course of the clinical trial administrative activities; the administrative close formalities and archive phase.

Job requirements

Professional experience

• Administrative in health sector

Education and training

• CFGS in health documentation and administration
• Education in clinical trials and specific training in national and international regulatory (CTA)
• Certifyed training in Good Clinical Practices 

Technical & soft skills

• MS Office (Outlook, Word, Excel)
• Clinical trials case report forms
• Documentation and electronic signatures
• To organize, order and perform different activities with knowledge of their influence on the final outcome of a process
• Understand the points of view of other peole, give help
• Ability to work under pressure

Languages

• Good command of the English language

We will value, but not required

• Previous experience in regulatory issues in other hospitals, CROs or sponsors

• Familiarity with REEC web, CTIS portal, EudraCT and clinicaltrials.gov portal

What do we offer

• No. of positions:   1

• Estimated start date:  September 2023

• Contract duration: Replacement position

• Estimated annual gross salary:  25.600 €

• You will be part of a multicultural team. We have a fun loving and friendly international work environment.

• Flexible working schedule - We know you have a life outside of work and we will work with you to make sure it's kept that way.

• Possibility to work some days in remote -Teleworking

• 26 working days of holiday per year

• System of accumulated hours for employees, from 88 to 104 hours depending on the year (11 to 13 working days), to attend to personal matters.

• Paid leave package

• Benefits of constant training are offered

• We offer and promote diverse and inclusive conditions. Applicants are made free from any discrimination. Specifically IDIBELL works to improve gender equality in all areas with the aim of achieving gender balance, but maintaining the most scrupulous respect to any choice at the level of gender identity. Please express yourself freely, safely and non-binarily, if that's the case.

Deadline: Please submit your application by  03/09/2023

Data protection notice

In compliance with the obligations established in the General Regulation of Data Protection (RGPD), which is the Regulation (EU) 2016/679 of the Parliament and of the Council, of April 27, 2016, and the Organic Law 3/2018, of December 5, Protection of Personal Data and guarantee of digital rights, it is reported that the Institut d'Investigació Biomèdica de Bellvitge (IDIBELL), CIF G58863317, with address Av. Granvia de l'Hospitalet, 199-203, 08908, L'Hospitalet de Llobregat, will process your personal data, as the controller, to apply for the position, maintain communication concerning the status of the candidature, to access the delivered CV; to compare that your data is in accordance with the offers announced by IDIBELL and to verify, where appropriate, that the information provided is accurate. You can find more information in our Privacy Policy at https://idibell.cat/en/privacy-policy-2/, request more information about the data processing carried out and exercise your rights of access, rectification, deletion, opposition, portability, limitation of processing by sending a request at email: dataprotection@idibell.cat. If you consider that you have not obtained satisfaction in exercising your rights, you may submit a claim to Catalan Data Protection Authority.

Our institute

IDIBELL is a research center that integrates the biomedical research of the Bellvitge University Hospital (HUB), the Catalan Institute of Oncology (ICO), and the University of Barcelona in the Bellvitge Campus (UB), and the Viladecans Hospital (HV). The research focuses of IDIBELL are cancer, neuroscience, translational medicine and regenerative medicine. Research, innovation and society are the pivots on which researchers work every day in order to improve the quality of life of citizens.

Observations:

The 'HR Excellence in Research' award represents IDIBELL’s commitment to the implementation of Human Resources policies, which oversee the attracting and development of talent in an open, transparent, and based on personal merit, in alignment with the principles of the European Charter for Researchers and the Code of Conduct for the Recruitment Researchers (Charter and Code).