Internationally renowned, the coordinating physician is responsible for the overall CIC policy and in particular for the safety of individuals, the scientific quality of the work carried out in the research unit and the management of the service. He is assisted by the delegated doctor and the quality referent. The latter is responsible for the development and continuous improvement of the quality system in accordance with the CIC quality policy.
Regular training of CIC-P staff in regulatory research requirements, quality system procedures and safety standards (fire, emergency procedures, etc.) guarantees quality clinical research focused on volunteer safety. Furthermore, a good command of written and oral English is essential for conducting international research projects.
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In order to ensure the safety of the volunteers and to obtain quality research, the clinical trials coordinator, in collaboration with the medical delegate, matches the qualified personnel with the requirements of the protocols, in a state-of-the-art material and technical environment.
The Clinical Trials Coordinator is responsible for enforcing the safety and quality requirements of clinical research as well as the rigor of the work organization in a multidisciplinary team.
With expertise and excellence, the Clinical Research Nurse conducts research for nursing purposes with patients or healthy volunteers, in accordance with the protocol, the Good Clinical Practice and the regulations in force. She assists the investigator in conducting the study. It supports volunteers within the research unit, in and out of hospital departments, in doctors’ offices and in people’s homes. Their expertise and excellence have been acquired through a diversified experience in care and a solid research experience, supplemented by a specific university degree “Clinical Research Nurse”.
The nurse in charge of recruitment is to pre-select participants for clinical studies, according to the protocol’s criteria, in care services, medical practices, nursing homes, health associations. She is also looking for participants through ads in the media, social media and posters. After validation of the criteria, the investigating physician informs the participant about the study and answers his questions. After a reflection period, the participant signs a written consent and starts the search.
The Biological Collections Manager manages the collections of blood and urine samples from CIC study participants. In addition, it carries out some CIC-P specific analyzes on these samples. She works with project managers on the feasibility of budgeting studies and negotiates purchases and contracts with suppliers and partners. Finally, it manages the monitoring of the regulatory part and the logistics of imports and exports of biological samples. She works closely with the operational engineer at the biological sample storage center.
Development and management projects
Mastering the regulations in clinical research and Good Clinical Practices, the project manager is in charge of coordinating research projects from conception to closure on the regulatory, administrative, financial, logistical and organizational aspects in close collaboration with the holder of the project. project, the promoter and the various research professionals involved (data-manager, biostatistician, …).
Data managers provide the link between the clinical investigation and the biostatisticians by organizing the collection and delivery of the data required by the clinical research protocols. They develop the computer databases of research data and control the consistency and quality of these data. They are assisted by data entry operators, who carry out the computer acquisition of the data reported in the notebooks. By mastering business software and various regulations and standards in computer science and clinical research, the data-manager contributes to improving the quality of data from research in accordance with best practices.
The main mission of biostatisticians is to perform statistical analyzes in the context of clinical research. They bring their expertise from the design of the study (feasibility study, sample size, methodology, analysis plan, randomisation list) to the communication of the results in international peer-reviewed journals (section statistics, results of publications, response to committee experts), orienting and organizing the reflection of each. Biostatisticians are privileged interlocutors of French or English speaking project promoters.
The engineer in charge of the cardiovascular ultrasound laboratory carries out the cardiovascular investigations (arterial explorations, cardiac and pulmonary ultrasounds …) programmed at the CIC as part of the research protocols. It also manages the backup and analysis of collected data. He is also responsible for the continuous training of laboratory users (clinical research nurses, trainees …) and the quality of the data acquired. Finally, he participates in the activity of scientific valorization of the research in collaboration with the various investigators during the writing and the submission of the articles resulting from the service.
Administrative and logistic control
The management assistant is in charge of the administrative and financial component of the national and international projects supported by the CIC, from conception to closure of the projects. It organizes and ensures the operational follow-up of the actions, in collaboration with the various managers of the CHRU, INSERM and the University of Lorraine.
The bilingual scientific secretary has three main missions: assistantship (management of doctors’ diaries, travel, presentations, etc.); organization (setting up meetings internally and externally, in France and abroad); managing and monitoring relationships with all external service providers.
The computer engineer ensures the operational maintenance of computer systems, websites and networks. He is also responsible for the administration and installation of local and outsourced servers. It contributes to the resolution of minor (hardware malfunction, …) or major (connection problem, …) incidents. It assists users and also trains them in the use of business tools. In addition, he has a role of technical consultant and advisor for the various projects related to computer science. Finally, it ensures the quality control of the data backup of the service.