Description de fonction

068-2020 Quality Assurance Officer - CDI - 38h (h/f)

Détails de la société

The Institut Jules Bordet Clinical Trials Support Unit (IJB CTSU) is seeking a motivated Quality Assurance Officer for a full-time position (1 FTE).

The Clinical Trials Support Unit (CTSU) is a department of Belgium’s world-renowned cancer centre, Institut Jules Bordet (IJB), and has many years’ experience in the design, implementation and conduct of phase II and III and other clinical trials. Located in Brussels, Belgium, right in the heart of Europe, the team consists of about 60 members and works in collaboration with medical specialists.

Fonction

The Quality Assurance Officer works with the quality manager to ensure that clinical trials processes are conducted in accordance with GCP, guidelines and external partner’s contracts in place.

Job duties and responsibilities:

The Quality Assurance Officer:

  • Draft quality assurance policies and procedures in collaboration with the CTSU teams;
  • Communicate quality standards, procedures and specifications (quality management system);
  • Ensure timely review and maintenance of CTSU Standard Operating Procedures (CTSU SOP) in accordance with the defined timelines;
  • Draft CTSU SOP in close collaboration with CTSU teams;
  • Ensures IJB CTSU activities are carried out according to the Standard Operating Procedures, and ICH GCP regulations, study protocols, and study specific manuals and procedures;
  • Review essential study documents and organise training of study teams on these documents;
  • Provide support to Operation Staff on the application of, and adherence to processes and day to day use of CTSU procedures, templates and guidelines;
  • Maintain job descriptions, CVs and training records for CTSU employees up-to-date.

    The Quality Assurance officer reports to the Quality Manager.

Profil

Job requirements:

Profile:

  • Holds a degree in a field relevant to the proposed position
  • Relevant experience (minimum 1 year) in quality management
  • Knowledge of ICH-GCP and EU Directives applicable to Clinical Trials
  • Relevant experience in the Clinical Research field is an asset

Skills/competencies

  • English proficiency (written and oral)
  • Advanced writing skills including ability to summarize information and to provide clear instructions to non-specialist audience;
  • Advanced Microsoft Office skills (knowledge of Access ® is an asset);
  • Ability to work as a team member or independently with minimal supervision
  • Ability to prioritize multiple and varied tasks efficiently and accurately;
  • Excellent interpersonal, verbal and written communication skills
  • Ability to handle confidential information
  • Flexible attitude with respect to work assignments and new learning;

Offre

Offer:

  • Start date: as soon as possible
  • Full-time position (1 FTE)
  • Long term contract (CDI)
  • Position based in IJB, CTSU (7th floor)

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

  • Publiée le:mer. 6 janvier 2021
  • Lieu: Institut Jules Bordet
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