Position Details
About this role
This role involves managing clinical activities for medical device studies, focusing on surgical devices, ensuring compliance, and monitoring patient safety across multiple sites remotely.
Key Responsibilities
- Manage clinical study activities
- Monitor patient safety
- Perform site visits and training
- Ensure compliance with ICH-GCP
- Support remote clinical trials
Technical Overview
Scope includes clinical research in medical devices, with emphasis on surgical specialties, source data review, regulatory compliance, and remote site management using EMR/EHR systems.
Ideal Candidate
The ideal candidate is a senior-level Clinical Research Associate with over 5 years of experience in medical device clinical monitoring, particularly surgical devices. They should be proficient in source review, EMR/EHR systems, and capable of managing multiple study sites remotely.
Must-Have Skills
Nice-to-Have Skills
Tools & Platforms
Required Skills
Hard Skills
Soft Skills
Certifications
Preferred
Industry & Role
Keywords for Your Resume
Deal Breakers
Less than 5 years CRA experience, No medical device monitoring background, Lack of surgical device experience, Inability to travel up to 55%
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