Activ Surgical is seeking a highly motivated and detail-oriented Clinical Research Associate (CRA) to support the planning, execution, and monitoring of clinical studies for our advanced surgical visualization technologies. The CRA will play a critical role in pre-clinical trials, first-in-human trials, Phase I and Phase II studies, and ongoing clinical investigations across domestic and international sites. This position requires strong knowledge of FDA guidelines, Good Clinical Practice (GCP), and International Council for Harmonisation (ICH) regulations, with a proven ability to operate in fast-paced environments involving novel technologies.

QUALIFICATIONS

• Bachelor’s or Master’s degree in Life Sciences, Nursing, Biomedical Engineering, or related field.
• 2-5+ years CRA experience in medical device or biotech clinical trials; surgical device or imaging experience preferred.
• Demonstrated expertise in first-in-human studies, Phase I and II trials, and novel technology evaluation.
• Strong working knowledge of FDA, ICH, GCP, ISO 14155, and global regulatory frameworks.
• Experience with domestic and international site management and multi-country trial coordination.
• Excellent communication, organizational, and problem-solving skills.
• Proficiency in electronic data capture systems and common office software.
• Willingness to travel (15-25% domestic and international).

REQUIREMENTS

Support med tech validations studies, ensuring imaging or device integration endpoints are properly captured
Experience monitoring device trials, imaging / visualization platforms, or AI enabled systems strongly preferred.