Partner sites:EURESELA

Clinical Research Associate

by:  Luxembourg

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Conference on Harmonization - Good Clinical Practice: ICH-GCP) as well as the Clinical trials - Directive 2001/20/EC repealed by the Clinical Trials Regulation.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