Bordet-ctsu: Quality Assurance Officer
il y a 2 semaines
Fonction:
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.
The IJB-CTSU is seeking a motivated Quality Assurance Officer for a full-time position (1 FTE).
Position:
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.
Duties and Responsibilities:
- 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;
- Maintain job descriptions, CVs and training records for CTSU employees uptodate.
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 or willingness to get it
- Relevant experience in the Clinical Research field is an asset
Skills and competencies
- English proficiency (written and oral)
- Advanced writing skills including ability to summarize information and to provide clear instructions to nonspecialist audience;
- Advanced Microsoft Office skills (knowledge of Access is an asset);
- Ability to work as a team member or independently with mínimal 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;
Offer:
- Fulltime position (1 FTE)
- Long term contract (CDI)
- Opportunities for ongoing professional development
- Position based in IJB-
CTSU:
Rue Meylemeersch, 90 (Rez Haut Nord), 1070 Anderlecht
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