Clinical Study Support Officer (H/F/X)

Within the Clinical Trial Center (CTC), you provide regulatory, administrative, and methodological support for academic drug, medical device, or in vitro diagnostic studies for which Cliniques universitaires Saint-Luc is the sponsor or national coordinator.

As such, you:

• Support the setup of academic studies
  
  • Analyze the regulatory aspects of research projects.
  • Assist investigators in submission procedures to the Ethics Committee and competent authorities.
  • Coordinate the preparation of regulatory dossiers and ensure their compliance.
  • Guide teams toward the expert resources necessary for project development (methodology, statistics, data management, etc.).
  • Contribute to the evaluation of study feasibility and the preparation of risk and data management plans.
• Ensure regulatory follow-up of studies
  
  • Manage submissions and notifications to competent authorities and ethics committees.
  • Coordinate the follow-up of amendments, progress reports, and study closures.
  • Ensure the transmission of safety information and the regulatory registration of studies and their results.
• Contribute to the quality and compliance of research activities
  
  • Participate in the development, updating, and implementation of quality procedures and tools.
  • Contribute to clinical research accreditation and certification processes.
  • Ensure compliance with regulatory requirements and Good Clinical Practice.
• Train and support research teams
  
  • Provide coaching and support to investigators and clinical research coordinators.
  • Lead training courses regarding sponsor obligations, regulatory procedures, and tools provided by the CTC.
  • Participate in maintaining the continuity of CTC activities in collaboration with other team members.

 📚 Required qualifications and experience

• University degree with a pharmaceutical, scientific, or medical orientation, or equivalent experience in the scientific and regulatory aspects of clinical research;
• Training in clinical trial management;
• Mastery of Good Clinical Practice (GCP), ethical and scientific quality standards in accordance with the principles of the Declaration of Helsinki;
• Knowledge of the Directives, Regulations, and Standards governing clinical research. 
• Experience in the field of drug, medical device, or in-vitro diagnostic clinical research;
• Experience with a database management software and electronic CRF creation is an asset; 

🚀 Essential skills

• Flawless knowledge of French;
• Knowledge of written and spoken medical English;
• Basic knowledge of Dutch;
• Knowledge of computer software (Office automation, statistical software, databases, e-CRF). 

✨ Additional assets

• Team spirit, listening skills, communication, empathy, and negotiation skills;
• Stress resistance;
• Rigorousness and methodology;
• Sense of work organization and responsibilities;
• Spirit of initiative and synthesis;
• Ability to work autonomously and organize personal work;
• Ability to work interdisciplinarily;
• Ethics and respect for professional confidentiality;
• Desire for professional development and intellectual curiosity.