Clinical Research Associate

Team Description:

The Neuralink Clinical team is at the heart of an ecosystem that merges neuroscience, engineering, and medicine. We work to shape the future of brain-computer interface (BCI) technology through the planning, launch, and execution of groundbreaking human clinical trials. Our team is built on a foundation of excellence, aiming to uphold the highest standards of Good Clinical Practice (GCP) while redefining what’s possible and revolutionizing the way people interact with technology. Through strict compliance with ethical and regulatory protocols, we focus on ensuring the well-being of our trial participants while advancing the frontiers of neuroscience! Every day will bring fresh challenges and unprecedented opportunities to pioneer new approaches in the pursuit of our mission. From navigating regulatory pathways, designing trial protocols and documentation, and executing clinical trials, our team is instrumental in translating Neuralink’s BCI technology for use in people!

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. Additional job responsibilities will include:

• 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)