Clinical Research Associate

Stroke is the second leading cause of death worldwide, yet the general public, firefighters, and even non-specialist healthcare professionals often struggle to recognize it. Valuable time is lost during diagnosis, and by then it may be too late for emergency treatments. AI-Stroke is developing a “digital neurologist” to detect/confirm stroke using tablets already available in ambulances, saving precious time in a context where “Time is Brain.” Our AI models have been trained on the world’s largest dataset of videos of stroke patients. The company is supported by the French government (2023 i-Lab award from the Ministry of Higher Education and Research), the Occitanie Region (PIA grant), and Montpellier Métropole, which hosts us at the Hall de l’Innovation (Sud de France district). The company has recently raised €5 million to support its development through regulatory market authorization and is preparing to launch a large study in the United States, enrolling more than 10,000 patients across approximately ten U.
S. states. Our clinical trial is unusual: AI-Stroke is partnering with U.
S. Emergency Medical Services (“EMS”) organizations, not with hospitals. Such organizations do not do clinical research on a regular basis. The study is about acquiring videos of possible stroke patients; therefore, EMS staff are asked to video record patients during their standard stroke assessment. To support this study, we are recruiting an in-house CRA: you will be responsible for ensuring the study runs smoothly across the sites: following up with them on a day-to-day basis, sending reminders, ensuring that issues are corrected, and making sure that the data supporting our FDA authorization is reliable. Your main responsibilities will include:
• Remote monitoring of study sites (10 or more EMS organizations in the U.
S.) in accordance with our risk-based monitoring plan: centralized review of Key Risk Indicators (KRIs), signal detection and analysis
• Site follow-up and reminders: training and delegation logs, provision of patient information notices, handling opt-out requests, and ensuring data completeness
• Protocol deviation management: maintaining the issue and deviation log, conducting analyses, coordinating corrective actions with sites, and following issues through to closure
• Safety monitoring: follow-up of serious adverse events and device deficiencies, with reconciliation against our application’s technical logs
• Reporting: regular summaries for the study Steering Committee and contribution to the final report
• Document quality: contribution to the Trial Master File (TMF), preparation for audits and inspections, and drafting and improving procedures
• Coordination with internal teams (business development, QARA, DPO, software and AI teams) and the independent partner responsible for data and statistics, in strict compliance with the study’s blinding requirements

Location:
Montpellier (Halle de l’Innovation) partial remote work possible (full remote is possible only if you are US based). Monitoring is conducted entirely remotely, but the time difference with the U.
S. requires regular communication and meetings toward the end of the working day. The position is either a part-time job (~30%) or a freelance position. Candidate Profile Required o Minimum bachelor’s degree (master’s degree would be appreciated) + dedicated training as a CRA (e.g. DIU FARC-TEC) o At least 5 years of experience as a CRA / Clinical Research Associate, ideally with remote monitoring experience o Strong command of Good Clinical Practice (ICH E6), with up-to-date GCP training o Totally fluent in English and in French: your day-to-day contacts will be based in the U.
S. but your colleague are mostly French (ideally English is your mother tongue) o Highly rigorous and organized, with the diplomacy and strong communication skills needed to follow up effectively while developing and maintaining strong site relationships Preferred o Experience with medical device clinical studies (ISO 14155), ideally involving software or AI o Knowledge of the U.
S. regulatory environment: FDA, IRB, HIPAA o Knowledge of prehospital emergency care or stroke management o Comfort with digital tools: eCRFs, dashboards, Microsoft 365 You are also autonomous and methodical, and you care about doing things properly. You know how to be both demanding and supportive with study sites, and you do not hesitate to escalate an issue when needed. You want your work to have a meaningful impact; helping bring to market a solution that can save lives would be a major source of motivation and fulfillment for you.