Clinical Research Associate | EURES

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Conference on Harmonization - Good Clinical Practice: ICH-GCP) as well as the Clinical trials - Directive 2001/20/EC repealed by the Clinical Trials Regulation.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

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601462.pdf

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