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.
- 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.

**In Short...**:

- Contract type : Fixed-term contract (CDD)
- Contract duration : 12 months
- Location : rue Thomas Edison 1 A-B - 1445 LUXEMBOURG
- Start date : 01/04/2025
- Ref : JA/CRA0225/MA/CRMT

**How to apply**:
Applications including a letter detailing your motivation and a curriculum vitae should be sent through our website.