Medical Device & Diagnostics CRA 2 – US Remote (French Speaking)

About the role

We are looking for an experienced Clinical Research Associate (CRA) Level 2 to join our Medical Device & Diagnostics team. The position is US‑based, remote, and requires French language proficiency and the ability to travel to Canada for site visits.

Key responsibilities

• Perform all aspects of site monitoring, including routine visits, initiation, close‑out, and maintenance of study files.
• Conduct pre‑study visits, liaise with vendors, and manage site activities according to project plans.
• Ensure informed consent, protocol compliance, and data integrity on case report forms and electronic data capture systems.
• Manage registries, conduct feasibility work, and report serious adverse events (SAEs) with narratives and follow‑up.
• Review CRFs, generate and resolve queries using Fortrea or other client data management systems.
• Assist in training new staff, act as a local project coordinator, and support other duties as assigned.

Required profile

• University or college degree, or allied health certification (e.g., nursing licensure).
• 1‑3 years of clinical monitoring experience in medical device or diagnostics trials.
• Fluent in French and able to travel 60‑70% of the time (7‑9 days per month) to Canada.
• Comfortable in a fast‑paced, technology‑driven environment with changing priorities.

Required skills

• Clinical monitoring and site management.
• Electronic Data Capture (EDC) systems – Fortrea.
• Serious adverse event (SAE) reporting.
• CRF review and query resolution.

What we offer

• Comprehensive medical, dental, vision, life and disability insurance.
• 401(k) retirement plan.
• Flexible paid time off (PTO) plan.
• Opportunities for professional growth within a collaborative team.