Clinical Research Associate - MA0822

1A-B, rue Thomas Edison, Strassen L-1445, Luxembourg
21/09/2022 11:43:52

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 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.


IN SHORT...

  • Contract type:    1-year fixed-term contract
  • Work hours:        Full time
  • Location:             Strassen
  • Start date:          ASAP
  • Ref:                        JA/CRA0822/MA/CRMT

HOW TO Apply

    Applications including a cover letter and a  curriculum vitae should be sent through our website before 15 September 2022 via the apply button below. Please apply ONLINE formally through this web page. Applications by email will not be considered.