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About Neuralink

Neuralink is innovating bi-directional brain interfaces aiming to restore motor function to paralyzed individuals, enable sight recovery among the blind, and transform human interaction with digital platforms. The Clinical team operates at the nexus of neuroscience, engineering, and medicine to design and execute pioneering human clinical trials adhering to the highest Good Clinical Practice (GCP) standards. They emphasize participant welfare and regulatory compliance while pushing the frontiers of brain-computer interface technology.

Job Overview

As a Clinical Research Associate (CRA), you will contribute significantly to planning, launching, and managing neurologically-groundbreaking clinical studies. Your responsibilities include site management, ensuring protocol and regulatory conformity, monitoring safety, and maintaining critical data accuracy through both remote and onsite visits. You will collaborate with cross-disciplinary teams and external partners to facilitate Neuralink’s mission in advancing clinical trial methodologies for innovative brain interface devices.

Key Responsibilities

Conduct site initiation, interim monitoring, and close-out visits both remotely and in-person.
Ensure all studies comply with protocol, GCP, ISO 14155, and regulations such as 21 CFR Part 812.
Perform source data verification and review to guarantee clinical trial data integrity and completeness.
Monitor participant safety by reviewing adverse events, serious adverse events, and device issues thoroughly and promptly.
Maintain and verify regulatory documentation including Investigator Site Files, informed consent, and essential study documents.
Track and analyze site performance metrics including enrollment and data quality, proactively addressing risks and applying mitigation plans.
Conduct training sessions for sites regarding protocol adherence, device usage, and study procedures.
Collaborate with Clinical Operations, Data Management, Regulatory, and Quality departments to ensure operational excellence.
Manage data queries and protocol deviations promptly to preserve study integrity.
Prepare detailed monitoring reports and follow-up communications within designated timelines.
Support site readiness for audits and inspections.

Qualifications

Bachelor’s degree in life sciences, engineering, or a related discipline.
Minimum 5 years of clinical research experience, preferably involving medical devices.
Solid knowledge of GCP (ICH E6), ISO 14155, and FDA regulatory requirements.
Experience with electronic data capture (EDC) platforms and clinical trial documentation processes.
Comprehensive understanding of clinical trial monitoring and site management practices.
Outstanding communication, organizational, and analytical skills.
Self-driven and capable of thriving in a dynamic, fast-changing environment.
Availability for up to 30% travel, domestically and occasionally internationally.

Preferred Experience

Background with neuromodulation, implantable, or Class III medical devices.
Experience supporting Investigational Device Exemption (IDE) or Premarket Approval (PMA) studies.
Familiarity with risk-based monitoring techniques.
Involvement in early feasibility and first-in-human clinical trials.
Exposure to regulatory market approval clinical studies.
Willingness to travel between 30% to 50%, including international destinations.

Compensation and Benefits

The anticipated base salary spans from $89,000 to $148,000 annually, dependent on expertise and education. Additionally, Neuralink grants equity compensation through Restricted Stock Units (RSUs) to full-time employees, linking success to company growth.

Opportunity to shape innovative technologies alongside leading experts.
Career advancement potential with merit-based rapid promotions.
Comprehensive medical, dental, and vision insurance via PPO plans.
Paid holidays and commuter benefits.
Provided meals during work hours.
Equity participation excluding temporary or intern positions.
401(k) retirement plan eligibility (with some exceptions for interns).
Parental leave and flexible time off benefits available to full-time staff.

Clinical Research Associate