Clinical Research Associate

The Clinical Research Associate works 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

Site coordination & monitoring 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.

Data Management accountabilities:

• Contribute to the design, development, and review of eCRF forms, ensuring that fields, workflows, and edit checks are aligned with the study protocol and operational feasibility.
• Participate in User Acceptance Testing (UAT) of the electronic data capture (EDC) system by testing the eCRF, workflows, queries, and system functionalities before database go‑live.
• Perform data review and data cleaning activities, including identifying data discrepancies, reviewing system-generated queries, and resolving issues in collaboration with investigators and Data Managers.
• Support database lock activities, ensuring that all data are complete, consistent, and appropriately verified before the lock.

Key Accountabilities

• 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.
• Good understanding of EU and Luxembourg research regulation frameworks, including patient rights, data protection (GDPR), Clinical Trial Regulation (CTR), and procedures of the CA and EC.
• Familiarity with EU and international regulatory frameworks for clinical research, data protection, and the secondary use of data and samples (e.g. CTR, GDPR, ICH-GCP, MDR).
• 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 recruitment and promotion of female leaders and their career development.