Clinical Research Associate

About Neuralink:

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 whats 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 Neuralinks BCI technology for use in people!

Job Description and Responsibilities:

As a Clinical Research Associate youll 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. Youll 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 youll be at the forefront of Neuralinks mission to push the boundaries of whats 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:

• Bachelors 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 3050% (domestic and occasional international)