center
Description de fonction

IJB-CTSU: Regulatory Affairs Assistant 38h (h/f/x) - CDI

Détails de la société

The Institut Jules Bordet is an integrated multi-disciplinary centre, unique in Belgium and with an international reputation. The hospital is an academic non-for-profit organisation devoted entirely to patients affected by cancer.

The Clinical Trials Support Unit (CTSU) is a department of the Institut Jules Bordet and fights cancer through the design, set-up and conduct of innovative clinical studies that matters for patients.

With an experience of more than 20 years, we, at the CTSU, propose a wide range of services in clinical study management, from scientific support to operational activities. We promote an academic research while encouraging collaborations with other academic partners and pharmaceutical companies.

The IJB-CTSU is now looking for a Regulatory Affairs Assistant

Fonction

Position

The Regulatory Affairs Assistant (RAA) works closely with the Regulatory Affairs Manager (RAM). They ensure that both the clinical trials which fall either under the Directive 2001/20/EC or the EU Regulation N°536/2014 when applicable, and other clinical studies which are run under the Sponsorship of Institut Jules Bordet are authorized and conducted in accordance with the European directives and regulations, international guidelines, and national laws when applicable.

The tasks and responsibilities listed below might not be applicable for all projects, additional tasks and responsibilities might be assigned to the RAA according to his/her skills and qualifications.

Duties and Responsibilities:

  • Compile, submit and follow-up clinical study applications to Ethics Committees and/or Competent Authorities (initials, amendments, end of clinical study if applicable, final study report) in line with regulatory requirements and applicable national laws across different countries;
  • Ensure timely answers to questions raised by Competent Authorities and/or Ethics Committees;
  • Ensure appropriate management of study documents such as filing, processing and quality control;
  • Update and maintain the regulatory specific tracking system;
  • Act as a point of contact for Institut Jules Bordet on regulatory matters;
  • Organize meetings, prepare agendas and minutes;
  • Attend meetings and/or teleconferences on behalf of the RAM.

The RAA Reports to the RAM.

Profil

Requirements:

Profile

  • Holds a degree in the paramedical, biomedical or scientific field
  • Knowledge of ICH-GCP and legislations applicable to Clinical Studies
  • Relevant experience in the Clinical Research field is an asset

Skills and competencies

  • English proficiency (written and oral), as well as French and/or Dutch.
  • Advanced Microsoft Office skills
  • Attention to detail and strong organizational skills
  • Advanced writing skills including ability to summarize information
  • Ability to work as a team member or independently with minimal supervision
  • Excellent interpersonal, verbal and written communication skills and strong diplomatic skills
  • Flexible attitude with respect to work assignments and new learning
  • Ability to handle confidential information

Offre

Offer:

  • A full-time position with an open-ended contract
  • An opportunity to gain valuable experience in a dynamic academic environment
  • Possibility of homeworking
  • Opportunities for on-going professional development

For more information on the available position and environment, please follow the link https://ctsu.bordet.be

  • Publiée le:mar. 23 août 2022
  • Lieu: Institut Jules Bordet - Anderlecht
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