Clinical Research Associate

Job Description and Responsibilities

As a Clinical Research Associate, you'll play a crucial role in pioneering groundbreaking clinical studies. Your work will directly contribute to the planning, execution, and success of innovative trials, from the initial phases of study setup to hands-on clinical monitoring and site management. You'll be visiting sites both in-person and remotely to ensure protocol and regulatory compliance, tackle safety event management, and maintain essential documentation. Collaborating closely with a passionate, cross-functional team, as well as external partners, you'll be at the forefront of Neuralink's mission to push the boundaries of what’s possible in clinical research.

• Conduct site initiation, interim monitoring, and close-out visits (remote and on-site)
• Ensure clinical studies are conducted in accordance with protocol, GCP, ISO 14155, and applicable regulatory requirements (e.g., 21 CFR Part 812)
• Verify the accuracy, completeness, and consistency of clinical trial data through source data verification (SDV) and source data review (SDR)
• Monitor participant safety by reviewing adverse events (AEs), serious adverse events (SAEs), and device deficiencies for completeness and timeliness
• Ensure sites maintain adequate regulatory documentation, including Investigator Site Files (ISF), informed consent forms, and essential documents
• Track site performance, enrollment, and data quality metrics; proactively identify risks and implement mitigation strategies
• Support site training on protocol, investigational device use, and study procedures
• Collaborate cross-functionally with Clinical Operations, Data Management, Regulatory, and Quality teams
• Ensure timely resolution of data queries and protocol deviations
• Prepare and maintain monitoring reports and follow-up letters in accordance with timelines
• Support audit and inspection readiness at the site level

Required Qualifications

• Bachelor’s degree in life sciences, engineering, or related field
• 5+ years of clinical research experience (device experience strongly preferred)
• Working knowledge of GCP (ICH E6), ISO 14155, and applicable FDA regulations
• Experience with electronic data capture (EDC) systems and clinical trial documentation
• Strong understanding of clinical trial processes, including monitoring and site management
• Excellent communication, organization, and problem-solving skills
• Ability to work independently in a fast-paced, evolving environment
• Up to 30% travel (domestic and occasional international)

Preferred Qualifications

• Experience in neuromodulation, implantable devices, or other Class III medical devices
• Experience supporting IDE or PMA clinical studies
• Familiarity with risk-based monitoring approaches
• Exposure to early feasibility or first-in-human studies
• Exposure to market approval studies
• Willingness and ability to travel up to 30–50% (domestic and occasional international)

What We Offer

• Full-time employees are eligible for the following benefits:
• Opportunity to change the world and work with some of the smartest and most talented experts from different fields
• Growth potential; we rapidly advance team members who have an outsized impact
• Excellent medical, dental, and vision insurance through a PPO plan
• Paid holidays
• Commuter benefits
• Meals provided
• Equity (RSUs)
• 401(k) plan
• Parental leave
• Flexible time off