Clinical Research Associate -full time of freelance - Montpellier

Job Description

"Stroke is the second leading cause of death worldwide, yet delayed diagnosis often prevents timely emergency treatment. AI-Stroke is developing a “digital neurologist” for ambulance tablets—trained on the world’s largest dataset of stroke patient videos—to rapidly detect strokes, because “Time is Brain.” Backed by the French government (2023 i-Lab award), Occitanie Region, and Montpellier Métropole, the company recently raised €5 million toward regulatory approval and is launching a U.S. clinical study of over 10,000 patients across ten 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, 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 / near Sud de France) 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.

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.

Compensation

• Gross salary 40 k€ annual
• Tickets restaurant 10 € / day paid at 60% by the company