Clinical Research Associate
About The Position
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
- 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
- Excellent medical, dental, and vision insurance through a PPO plan
- Paid holidays
- Commuter benefits
- Meals provided
- Equity (RSUs) Temporary Employees & Interns excluded
- 401(k) plan Interns initially excluded until they work 1,000 hours
- Parental leave Temporary Employees & Interns excluded
- Flexible time off Temporary Employees & Interns excluded
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
251-500 employees
