Description

As a Clinical Research Associate at Neuralink, you will play a crucial role in pioneering groundbreaking clinical studies. You'll be responsible for planning, executing, and monitoring innovative brain-computer interface trials, ensuring protocol and regulatory compliance while working with a passionate team to push the boundaries of clinical research.

Requirements

• Bachelor's degree in life sciences, engineering, or related field
• 5+ years clinical research experience (device experience strongly preferred)
• Working knowledge of GCP (ICH E6), ISO 14155, and FDA regulations
• Experience with electronic data capture (EDC) systems and clinical trial documentation
• Ability to work independently in a fast-paced environment and travel up to 30%

Responsibilities

• Conduct site initiation, interim monitoring, and close-out visits (remote and on-site)
• Ensure studies comply with protocol, GCP, ISO 14155, and FDA regulations (e.g., 21 CFR Part 812)
• Verify clinical trial data accuracy through source data verification (SDV) and review (SDR)
• Monitor participant safety by reviewing adverse events (AEs, SAEs) and device deficiencies
• Track site performance, enrollment, and data quality metrics; identify risks and implement mitigations