The Institute of Tropical Medicine (ITM) is internationally recognised as a centre of excellence for education, research and service provision in the field of tropical medicine. The Clinical Trials Unit (CTU) collaborates with clinical researchers at ITM and at partner institutions. The CTU is setting up and conducting non-commercial clinical trials as well as other studies in humans which address health problems in Belgium and in resource-limited settings in the South.
- You are responsible for clinical trial 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;
- 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 will 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 prioritise 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.
The ITM is an open and international campus where staff, students and researchers work on the new international health challenges. We strive for excellence, integrity, specificity and efficiency. Your assignment contributes to our mission. We value human dignity and diversity, academic creativity and a critical spirit, solidarity and cooperation, and the well-being of employees, students, patients and clients. Together we ensure a pleasant working atmosphere with attention to work-life balance and opportunities for training. We offer you:
- 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.
For more information contact HR (email@example.com). Send your CV with your letter of motivation to firstname.lastname@example.org before 8 November 2020.
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