Regulatory Specialist - Cancer Clinical Trials

Ref.: 24-058_SS_VN

About the unit

ICO-L'Hospitalet is a leading hospital in cancer clinical research. Its Clinical Research Unit (UIC) has actively participated in 612 clinical trials throughout 2023, with 663 patients choosing to enroll. These trials often investigate cutting-edge therapies for cancer, with investigators specializing in the latest advancements in treatment modalities. The UIC boasts top professionals dedicated to conducting even the most challenging clinical trials.

About the role

The Regulatory Specialist in Clinical Trials Administrative Management will oversee the coordination of documentation in compliance with clinical trial regulations among three key parties: the site investigator's team and delegated personnel, the site management team, and sponsors or CROs (Contract Research Organizations). This role entails involvement in all stages of the trial, including proposal submission, approval processes with independent review boards and Spanish and European regulatory agencies, management of administrative activities throughout the trial duration, and completion of formalities for trial closure and archiving.

Job requirements

Professional experience

• Administrative experience in the health sector

Education and training

• Secondary education (upper degree or CFGS) in Health Documentation and Administration
• Education in clinical trials and specific training in national and international regulatory compliance (CTA)
• Certified training in Good Clinical Practices

Technical & soft skills

• Clinical trials Case Report Forms (CRFs)
• Documentation and electronic signatures
• Proficiency in MS Office (Outlook, Word, Excel)
• Organizational skills to coordinate and execute various activities with insight into their impact on final process outcomes
• Ability to understand others' perspectives and provide assistance
• Capacity to work effectively under pressure

Languages

• Fluent in Catalan, Spanish, and English.

We will value, but not required

• Previous experience in regulatory affairs at 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: July 2024
• Contract duration: Permanent linked to projects.
• Estimated annual gross salary: 26.220 €
• 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 07/07/2024

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).

IDIBELL is committed to the principles of the Code of Conduct for the Recruitment of Researchers of the European Commission and the implementation of open, transparent and merit-based recruitment (OTMR).