Job Description

We are partnering with an innovative medical device company seeking an experienced Clinical Research Associate (CRA) to support global clinical studies within a fast-paced, collaborative environment. This individual will play a key role in managing and monitoring clinical trial activities (up to 50% US travel -2x/month) to ensure studies are conducted in compliance with protocols, GCP, FDA regulations, and company SOPs.

Your role with the company:
• Site qualification, initiation, monitoring, and close-out visits
• Building strong relationships with clinical sites and investigators
• Ensuring accurate data collection and protocol compliance
• Supporting audit and inspection readiness activities
• Assisting with site feasibility, training, and issue resolution
• Cross-functional collaboration with Clinical, Regulatory, Safety, and Data Management teams

Desired Profile:
• 5+ years of CRA experience
• Minimum 2 years of medical device monitoring experience
• Experience supporting international/multi-region studies outside the US
• Strong knowledge of ICH-GCP and FDA regulations
• Ability to manage multiple priorities independently in a remote environment
• Experience with EDC systems and clinical trial management tools

Preferred:
• Class II / Class III medical device experience
• Startup company experience
• Comfortable working remotely with leadership/team members

This is an exciting opportunity to join a growing organization where you'll have visibility, ownership, and the ability to make a meaningful impact on clinical programs.

Job Tags

Remote work

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