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 Systems Engineer, you will build, integrate, and improve the technical systems, data workflows, and tools that enable Clinical to execute trials efficiently, maintain high-quality data, and scale clinical operations Additional job responsibilities will include:

• Own and improve Clinical's internal systems, tools, and data workflows across clinical trials.
• Build automated workflows and tools that reduce manual work for Clinical and site-facing teams.
• Integrate data across clinical systems and internal engineering/data, analyze data, create infrastructure to create reliable sources of truth for trial execution.
• Develop dashboards, reporting tools, and automated metrics for all clinical data, including enrollment, participant status, site performance, study milestones, data quality, and operational KPIs.
• Identify recurring manual or error-prone Clinical processes and design technical solutions to automate or simplify them.
• Build tools that improve clinical data review, reconciliation, quality control, and issue identification.
• Partner with Clinical, Software, Data, Product, and Engineering teams to translate clinical needs into technical requirements and deploy solutions.
• Support validation, documentation, access controls, traceability, and change management for systems used in regulated clinical workflows.
• Troubleshoot clinical systems and data-flow issues and drive root-cause resolution rather than relying on manual workarounds.
• Establish scalable infrastructure and standards that can support increasing numbers of participants, sites, studies, and indications.

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)