Clinical Research Associate

The Clinical Research Associate work at LIH’s Clinical and Epidemiological Investigation Center. She/He will:

 Coordinate clinical research projects according to the protocol, budget and fixed timelines.

 Supervise and assist regulatory submissions to health authorities including the national research ethics committee.

 Support private sponsors, researchers and investigators from other research institutions or hospitals in the set up

and conduct of clinical research projects.

 Ensure compliance with the applicable legal, administrative and regulatory requirements.

 Provide specific expertise and know-how in clinical research.

 Provide support to safety reporting and adverse events reporting.

 Monitor clinical trials and guarantee the quality of the scientific data collected during the study.

Key Skills, Experience and Qualifications

 Master’s degree in the field of Medical/Health, Biomedical, or Life Sciences or Biology/Biotechnology related sciences.

 Certified clinical research training (DIU-FARC, DIU-TEC, etc.).

 At least 2 years of experience in the domain of clinical research (CRO, clinical trial unit or research centre, pharmaceutical industry) including a significant on-site monitoring experience.

 Experience in multi-center international clinical trials.

 In-depth knowledge of the clinical research working rules in Luxembourg/Belgium and Europe (legal context, patient rights, data protection, etc.) and the international directives (International Conference on Harmonization - Good Clinical Practice: ICH-GCP) as well as the Clinical trials - Directive 2001/20/EC repealed by the Clinical Trials Regulation.

 Knowledge of regulatory requirements for clinical trials.

 Ability to interact positively with advisors and regulatory authorities.

 Independent and multidisciplinary team working abilities, meticulous, motivated, creative and scientifically innovative.

 Strong oral and written communication skills, be able of summarising ideas and prioritising.

 Language skills: Fluent in French and English. Any other commonly spoken language in Luxembourg such as Portuguese, German or Luxembourgish would be an added advantage