Clinical Research Associate Monitoring M/F

Under the responsibility of the internal promotion manager:

• Ensures the quality control of data for internal promotion studies for all investigator sites.
• Ensures the regulatory compliance of documents across different sites, checks the adequacy of clinical data entered in the case report form with the patient's medical record, and ensures that adverse events are properly reported to the sponsor.
• Depending on needs, the CRA:
• participates in project reviews,
• participates in the development and drafting of documents such as case report forms, data entry guides, monitoring plans, and manuals.
• participates in the logistical organization of trials,
• manages the internal follow-up of SAEs in collaboration with pharmacovigilance/materiovigilance (requesting additional information from investigator sites, entering these SAEs into a database)
• Also performs site initiation and close-out visits for these studies, as well as continuous follow-up of investigator sites, in collaboration with the project manager for internal promotion.
• Participates in the drafting and updating of quality documents related to these missions

Qualifications (Degrees):

• Initial training in the field of life sciences or the medical field
• Scientific background (Master's degree or higher)
• Driver's license B
• Training and/or experience in clinical research (DIU FARC or FIEC or equivalent)
• Knowledge of current regulations regarding clinical research
• Proficiency in IT tools: Word, Excel, Power Point, Internet, email
• Scientific English: written and oral comprehension
• Rigor
• Organizational skills,
• Writing skills
• Availability and flexibility
• Strong interpersonal skills/ease of communication
• Mobility outside CHR Metz-Thionville: interregional and national travel, particularly to investigator sites associated with projects promoted by CHR METZ-THIONVILLE
• Rigor and organization