Department of Clinical Sciences - Clinical Trials Unit
More than 500 staff members at the Institute of Tropical Medicine (ITM) contribute every day to improving the health of millions of people worldwide. Our researchers conduct more than 100 scientific projects in the fields of tropical medicine and international health. Our teaching staff welcomes more than 500 professionals from around the world each academic year to attend our highly regarded medical courses. Tens of thousands of travel- and STI consultations take place in our clinic each year, and our internationally recognized reference laboratories examine many hundreds of thousands of samples.
There is only one way we can accomplish these very diverse tasks: thanks to a great passion for our mission.
Would you like to be part of this impactful work? Would you like to be involved in the clinical trials of the ITM?
Then this is your chance! ITM is a renowned internal institute that aims to improve global healthcare through scientific research. The Clinical Trials Unit (CTU) of ITM supports academic clinical trials which address health problems in Belgium and overseas in resource-limited settings.
You will join a dynamic group of clinical trial scientists (clinical project managers), data managers and biostatisticians who, together with the clinical trial site teams, ensure the meticulous preparation, execution and reporting of various clinical trials and other clinical research projects. After an introductory period, you will have a varied range of tasks with a high degree of independence and a team of CTU-colleagues on which you can rely for feedback and support.
Job description
* You are responsible for full 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 (in Belgium, but mainly overseas in resource limited settings);
preparation of investigator files;
maintenance of trial master files, pharmacovigilance, and other GCP-related tasks.
* You will mainly coordinate and monitor phase II/III clinical trials, as well as diagnostic studies or other studies in humans, carried out in Belgium and overseas in resource-limited settings.
* You will participate in courses of the CTU related to Good Clinical Practices (GCP).You assist in training of young researchers involved in clinical research, both in Belgium and overseas in resource-limited settings.
* You report to the Head of the Clinical Trials Unit (Yven Van Herrewege).
Profile
* 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, experience with academic studies in resource limited settings is an asset.
* You have demonstrated clinical project management skills and are used to set-up, coordinate and follow-up clinical trial operational activities as a sponsor representative and in collaboration with principal investigators and site teams.
* You have experience in the preparation and submission of a clinical trial dossier to regulatory authorities and ethical committees in Belgium.
* You have a good knowledge of ICH-GCP, EU Directives, and applicable Belgian laws. Knowledge of EU Regulation 536/2014 is an asset.
* You have good presentation skills and you are willing to participate in educational activities.
* You are a team player and problem solver with a pro-active mindset. You are able to prioritize when confronted with a high workload and have excellent communication skills.
* You are available for short travels (up to 2 weeks), mainly overseas and predominantly to resource-limited settings (potentially including countries or regions with political instability or unrest).
* You are stress-resistant and able to work in quickly changing environments with short deadlines, flexibility is key.
* You have good knowledge of Office applications; experience with electronic data management systems is a plus.
* You have excellent knowledge of English and Dutch and at least a basic knowledge of French.
Offer Groepsverzekering Maaltijdcheques ITM is an open and international campus where staff, students and researchers work on the new international health challenges. Together we ensure a pleasant working atmosphere, with attention to work-life balance, with opportunities for training, growth and development. We offer you:
* A fulltime employment as a scientific assistant, open-ended contract. Starting date as soon as possible.
* A workplace in the middle of the vibrant city of Antwerp, easily accessible by public transport.
* A salary package depending on your profile and professional experience, and supplementary benefits, such as private pension scheme, meal voucher subscription and reimbursement of transport.