Clinical Trials Scientist
- Instituut voor Tropische Geneeskunde
- Fixed-term, Full-time
Clinical Trials Scientist
- You are responsible for clinical trials management, including, but not limited to: project planning and coordination; assisting in writing of clinical trial protocols, informed consent forms and other essential documents; ethical and regulatory submissions; study monitoring; maintenance of trial master files; pharmacovigilance; and other GCP-related tasks.
- You will mainly monitor phase III/IV non-commercial clinical trials as well as diagnostic studies or other studies in humans, carried out in Belgium and overseas in resource-limited settings.
- You will assist in training of young researchers involved in clinical research in Belgium and in resource-limited settings.
- You report to the Head of the Clinical Trials Unit.
- • You hold a Master in Medical sciences, Biomedical sciences, Pharmacy or in other relevant life sciences.
- You have at least two years of experience in monitoring and coordination of GCP-compliant clinical trials, preferably in an academic setting. You have experience in the preparation and submission of a clinical trial dossier to regulatory authorities and ethical committees.
- Previous experience in resource-limited settings, training in tropical medicine, experience in laboratory quality systems are assets.
- You have a good knowledge of ICH-GCP, EU Directives, EU Regulation 536/2014 and applicable Belgian laws.
- You have good presentation skills and you are willing to participate in educational activities.
- You are a team player and problem solver. You are able to prioritize when confronted with a high workload and have excellent communication skills.
- You are available for frequent short travels (up to 2 weeks), both in Europe and overseas (mainly developing countries).
- You have excellent knowledge of Office applications; experience with electronic data management systems (MACRO and/or RedCAP) is a plus.
- You have excellent knowledge of English and French. Knowledge of Dutch is an asset.
- A fulltime employment as a scientific assistant for 1 year, extendable. Starting date as soon as possible.
- A salary according to the scales of the Flemish universities and to your work experience, with supplementary extra-legal benefits: a public transport subscription and/or bicycle fee, private pension scheme and meal vouchers subscription.
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- Group insurance
- Meal vouchers
- Company bicycle
- Public transport contribution
- 9 November
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