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Conference on Harmonization - Good Clinical Practice: ICH-GCP) as well as the Clinical trials - Directive 2001/20/EC repealed by the Clinical Trials Regulation.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