Clinical Research Coordinator Quality and Regulatory - MA0820

The Clinical Research Coordinator Quality and Regulatory work at LIH’s Clinical and Epidemiological Investigation Center. She/He will: Reference person for regulatory submissions to Health Authorities for LIH internal projects; Coordinate regulatory submissions of clinical research projects in collaboration with researchers, investigators, sponsors and authorities to obtain regulatory approvals according to the applicable regulatory framework; Interact and liaise with the Data Protection Officer and Head of Compliance Office at LIH to assure the quality process at CIEC and LIH; Ensure the quality management and development of the unit in close collaboration with the Head of unit, Clinical Research Manager and other CIEC staff; Organize and conduct internal audits to guarantee the respect of the quality system in place; Organize external audits and assist external auditors in order to obtain targeted certifications (ISO 9001, GCP, etc.); Coordinate clinical research projects from the start-up phase to the close out; Support private sponsors, researchers and other investigators in the set up and conduct of the clinical research projects.
1A-B, rue Thomas Edison, Strassen 1445, Luxembourg
28/08/2020 18:21:07
Key Accountabilities
  • Prepare all essentials documents in close collaboration with sponsors and investigators for submission of the research projects to regulatory authorities.
  • Be the interface between the various partners involved in clinical research projects including clinicians and researchers.
  • Be the main contact points for authorities: Follow submissions and reply to authorities’ questions and
    recommendations.
  • Ensure regulatory follow up of the projects in accordance with requirements (safety reports, etc.).
  • Collaborate with the Quality Unit of LIH to draw up best practice documents and quality plan for the unit.
  • Participate in the quality procedure evaluation process.
  • Draft and validate Standard Operating Procedures (SOPs) together with the other members of the team.
  • Prepare and conduct internal and external audits according to an audit plan in collaboration with the LIH Quality Unit.
  • Ensure that planned deviations and non-conformities of the system are documented and that relevant corrective and preventive actions (CAPA) or other improvements.
  • Coordinate multi-center projects with investigators.
  • Manage safety reporting of LIH driven clinical research projects and help reporting (serious) adverse events.

KEY SKILLS, EXPERIENCE AND QUALIFICATIONS
  • Master’s degree in the field of Medical/Health, Biomedical or Life Sciences or in Biology/ Biotechnology related sciences.
  • Certified clinical research training (DIU-FARC, DIU-TEC, etc.) or at least 5 years of experience in a similar position.
  • At least 5 years of experience in the domain of clinical research (CRO, clinical trial unit or research centre, pharmaceutical industry) including a significant experience in quality management and quality assurance.
  • Knowledge of regulatory requirements for clinical trials.
  • 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.
  • Thorough understanding of scientific topics and medical language, good knowledge of the health and clinical research environment.
  • Very good relational skills for the interaction with sponsors, researchers, physicians and health authorities, ability to interact positively with advisors and regulatory authorities, precision and excellent organizational skills.
  • Strong oral and written communication skills, be able of summarising ideas and prioritizing.
  • Independent and multidisciplinary team working abilities, meticulous, motivated, creative and scientifically innovative.
  • 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.

REF.: CM/CRCQR0820/MA/CIEC
CDI - Full time - Available immediately