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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.
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.
