Infirmier.re de Recherche Clinique

About This Role

The Clinical Research Nurse (IRC) assists the investigator throughout the research process, from initiation to closure, collaborating on single or multi-site research projects. This role operates under the responsibility of physician investigators within FEDER and INTERREG research projects.

Responsibilities

• Implement and monitor clinical trials on healthy or sick volunteers in cooperation with a healthcare team, adhering to good clinical practices and applicable laws.
• Liaise with various authorities in coordination with the medical coordinator (INSERM, Research and Innovation Department, etc.).
• Contribute to the proper functioning of the DRCI and the quality approach.
• Participate in technical committees and internal meetings.
• Ensure the quality and compliance of a study and measure investigator satisfaction.
• Organize the logistics required for a study under the responsibility of the investigator.
• Control and verify the conformity of documents necessary for the study's initiation (administrative, consent forms, questionnaires, etc.).
• Assist in establishing and managing study-related documents (administrative or organizational) or patient-related documents (files, CRFs, forms, questionnaires).
• Manage administrative tasks.
• Assist the investigator through essential protocol stages: screening, randomization, study exit, volunteer compensation.
• Help the investigator report adverse side effects.
• Ensure clinical monitoring of vital functions under the responsibility of the investigator.
• Administer study medications; manage side effects.
• Perform duties in compliance with protocols, "good clinical practices," and legal frameworks under the direction and control of the investigator.
• Collect and enter data related to clinical trial follow-up.
• Obtain information on the research in which they participate.
• Evaluate workload and interactions with other stakeholders (team members or external).
• Prevent possible dysfunctions and propose solutions with the study manager.
• Detect and correct inconsistencies in protocol execution or gathered data.
• Assist the investigator in managing DCFs.
• Manage stocks related to their function.
• Oversee emergency cart maintenance (planning and logistics) in coordination with the delegated physician and medical resuscitation department.
• Ensure liaison between various clinical research stakeholders.

Requirements

• Diplôme d’Etat d’Infirmier
• Experience in care

Qualifications

• Diplôme d’Etat d’Infirmier with experience in care