Senior Clinical Research Associate - ECRIN - MG1119

The Senior Clinical Research Associate will join the LIH’s Clinical and Epidemiological Investigation Center. She/He will: 1. Coordinate clinical  research projects according to the protocol, budget and fixed timelines determined 2. Support private sponsors, researchers and other investigators in the set up and conduct of clinical research projects.3. Ensure compliance with the legal, administrative and regulatory requirements both in Luxembourg and Belgium.4. Provide specific expertise and know-how in clinical research; provide support to safety reporting and help reporting  adverse events 5. Be the contact point in Luxembourg/Belgium for ECRIN studies under the supervision of European Correspondant for Luxembourg 6.Monitor clinical trials and guarantee the quality of the scientific data collected during the study
1A-B, rue Thomas Edison, Strassen 1445, Luxembourg
13/11/2019 09:23:48
Key Accountabilities
  • Be the interface between the various partners involved in clinical research projects
  • Conduct the regulatory submissions according to the applicable laws and obtain approvals.
  • Monitor and coordinate clinical research activities at different sites both at a national and international level including study design activities, safety reporting, monitoring 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. 

As CRA for ECRIN at an international level :

  • Provide leadership for ECRIN adopted clinical projects carried out in Luxembourg and Belgium and participate in the management of multinational projects
  • Provide advice and support to national investigators and sponsors wishing to develop European multinational studies through ECRIN
  • Monitor and coordinate the ECRIN activities according to the research protocols
  • Conduct regulatory submissions according to the applicable laws and obtain approvals
  • Set-up financial contracts and manage financial aspects during the projects.
  • Ensure on-site monitoring of clinical research projects at different sites, both nationally and internationally
  • Develop and maintain a good knowledge of the regulatory environment in other EU members states
  • Work closely with other members of the national network, research stakeholders, regulatory authorities and any other relevant professional bodies/organisations in Belgium and Luxembourg

KEY SKILLS, EXPERIENCE AND QUALIFICATIONS
  • Master’s degree in the field of Medical/Health or Life Sciences or Biology/Biotechnology related sciences.
    Certified clinical research training (DIU-FARC, DIU-TEC, …).
  • At least 5 years of experience in the domain of clinical research (CRO, clinical research centre, industry) and specifically as a CRA including a significant on-site monitoring experience.
  • Experience in multicenter international clinical trials.
  • Must know the working rules of clinical research 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, European directive on clinical studies).
  • Knowledge of regulatory requirements for clinical trials.
  • Ability to interact positively with advisors and regulatory authorities.
  • Independent and multidisciplinary team working,  meticulous, motivated, creative and scientifically innovative.
  • Strong oral and written communication skills, be able of summarising things and prioritising Language skills:
  • Fluent French, English and Dutch. Any other language of the European Union would be an added advantage

REF.: VD/SCRA1119/MG/CIEC
2 year fixed-term contract- Full time - Start date : ASAP