French‑Speaking Medical Device CRA 2 – US Remote (Travel)

About the role

We are looking for an experienced, French‑speaking Clinical Research Associate (CRA) to join our Medical Device & Diagnostics team. The position is US‑based, remote, and involves extensive travel (60‑70%) to Canadian sites for monitoring activities.

Key responsibilities

• Perform full‑cycle site monitoring, including pre‑study, initiation, routine visits, and close‑out.
• Maintain study documentation, manage study files, and liaise with vendors.
• Ensure informed consent, protocol compliance, and patient safety according to regulatory standards.
• Verify data integrity on Case Report Forms and electronic data capture systems.
• Conduct feasibility assessments, registry management, and Serious Adverse Event (SAE) reporting.
• Review CRFs, generate queries, and support data reconciliation.
• Assist in training new staff and act as a local project coordinator when required.

Required profile

• University or college degree in a health‑related field or relevant 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 to Canada regularly.
• Comfortable working in a fast‑paced, technology‑driven environment with changing priorities.

Required skills

• Clinical site monitoring and management.
• Electronic Data Capture (EDC) systems (e.g., Fortrea or similar).
• Serious Adverse Event (SAE) reporting.
• CRF review and query generation.

What we offer

• Comprehensive benefits package including medical, dental, vision, life insurance, 401(k), and paid time off.
• Opportunities to work with a leading medical device and diagnostics organization.
• Flexible remote work arrangement with regular travel to diverse clinical sites.