Clinical Research Associate with experience in regulatory activities

The Clinical Research Associate will work at LIH’s Clinical and Epidemiological Investigation Center. She/He will:

• Actively participate in writing of study protocols and other essential documents,
• Supervise and assist regulatory submissions to Competent Authority including the national Ethics Committee,
• Implement comments received from authorities in the essential documents,
• Coordinate clinical research projects according to the protocol, budget and fixed timelines,
• Be in charge of updating the project mangement system,
• Monitor clinical studies and guarantee the quality of the scientific data collected,
• 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.

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 clinical research (CRO, clinical trial unit or research centre, pharmaceutical industry) including a significant on-site monitoring experience,
• Experience in multi-center international clinical studies,
• In-depth knowledge of the clinical research working rules in Luxembourg/Belgium and Europe (legal context, patient rights, data protection, etc.) and the international regulations and guidelines (e.g., International Conference on Harmonization - Good Clinical Practice, the Clinical Trials Regulation, Medical Device Regulation, etc.)
• Familiar with risk-based approach
• 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.

Gender Equality

The LIH is an equal opportunities employer. We are fully committed to removing any discriminatory barrier related to gender, and not only, in recruitment and career progression of our staff. The LIH is attentive to gender representation among its leadership staff and aims to eliminate obstacles to the recruitment and promotion of female leaders and their career development.