Clinical Research Associate

Clinical Research AssociateAustin, Texas, United StatesWe 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.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!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 timelinessEnsure sites maintain adequate regulatory documentation, including Investigator Site Files (ISF), informed consent forms, and essential documentsTrack site performance, enrollment, and data quality metrics; proactively identify risks and implement mitigation strategiesSupport site training on protocol, investigational device use, and study proceduresCollaborate cross-functionally with Clinical Operations, Data Management, Regulatory, and Quality teamsEnsure timely resolution of data queries and protocol deviationsPrepare and maintain monitoring reports and follow-up letters in accordance with timelinesSupport audit and inspection readiness at the site levelBachelor's degree in life sciences, engineering, or related field5+ years of clinical research experience (device experience strongly preferred)Working knowledge of GCP (ICH E6), ISO 14155, and applicable FDA regulationsExperience with electronic data capture (EDC) systems and clinical trial documentationStrong understanding of clinical trial processes, including monitoring and site managementExcellent communication, organization, and problem-solving skillsAbility to work independently in a fast-paced, evolving environmentUp to 30% travel (domestic and occasional international)Experience in neuromodulation, implantable devices, or other Class III medical devicesExperience supporting IDE or PMA clinical studiesFamiliarity with risk-based monitoring approachesExposure to early feasibility or first-in-human studiesExposure to market approval studiesWillingness and ability to travel up to 30–50% (domestic and occasional international)The anticipated base salary for this position is expected to be within the following range. Your actual base pay will be determined by your job-related skills, experience, and relevant education or training. We also believe in aligning our employees' success with the company's long-term growth. As such, in addition to base salary, Neuralink offers equity compensation (in the form of Restricted Stock Units (RSU)) for all full-time employees.Base Salary Range: $89,000 - $148,000 USDFull-time employees are eligible for the following benefits listed below.An opportunity to change the world and work with some of the smartest and most talented experts from different fieldsGrowth potential; we rapidly advance team members who have an outsized impactExcellent medical, dental, and vision insurance through a PPO planPaid holidaysCommuter benefitsMeals providedEquity (RSUs) *Temporary Employees & Interns excluded401(k) plan *Interns initially excluded until they work 1,000 hoursParental leave *Temporary Employees & Interns excludedFlexible time off *Temporary Employees & Interns excluded