Clinical Research Associate (CRA) - MA0720

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.
1A-B, rue Thomas Edison, Strassen 1445, Luxembourg
24/07/2020 11:35:02

Key Accountabilities
  • Be the interface between the various partners involved in clinical research projects including clinicians and researchers.
  • Conduct the regulatory submissions according to the applicable laws and obtain approvals.
  • Set-up financial contracts and manage financial aspects during the projects.
  • Monitor and coordinate clinical research activities at different sites both at a national and international level including study design activities, initiation with all involved partners, monitoring, safety reporting and data management.
  • Collect data, report it in the CRF and check that the data entered is consistent with the medical record of each patient.
  • Participate in the quality procedure (evaluation process, drafting procedures, etc.), implementation of SOPs (Standard Operating Procedures) and their validation process.
  • Participate in European consortia and grant applications.
  • Ensure on-site monitoring of clinical research projects at different sites, both nationally and internationally.

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.

REF.: CM/CRA0720/MA/CIEC
2 year fixed-term contract - Full time - Available immediately