Clinical Research Associate

Neuralink•Austin, TX

About The Position

We are creating devices that enable a bi-directional interface with the brain. These devices allow us to restore movement to the paralyzed, restore sight to the blind, and revolutionize how humans interact with their digital world. 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.

Requirements

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)

Nice To Haves

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)

Responsibilities

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

Benefits

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
An 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