Clinical Research Associate
Custom Search Inc.
Clinical Research Associate (CRA)
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
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.
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