Team Description:

The Preclinical Team is responsible for designing, conducting, documenting, analyzing, and reporting preclinical studies. Our team provides a means for ensuring the safe, effective, and robust implantation of Neuralink devices into animals and, ultimately, humans.

Job Description and Responsibilities:

The Study Coordinator provides critical operational and project management support to the Study Director in GLP-regulated preclinical studies for Neuralink devices. This role handles the majority of day-to-day coordination, scheduling, data compilation, and administrative tasks, enabling the Study Director to focus on scientific oversight, data interpretation, and regulatory compliance. The Study Coordinator acts as a key liaison across the preclinical team, technical staff, and cross-functional groups to ensure studies progress smoothly, on time, and in compliance with protocols and SOPs. The Study Coordinator will:

• Support the Study Director in developing study protocols, amendments, and related documentation.
• Facilitate cross-functional communication, establish and track study timelines, and prepare/lead study milestone meetings.
• Identify and help eliminate roadblocks that could delay study progress.
• Assist with implementation of test methods and practices described in the study protocol and SOPs.
• Help ensure all experimental data, including observations of unanticipated responses of the test system, are accurately recorded and verified.
• Manage the study schedule, alerting the Study Director and team to critical data collection points or deadlines.
• Support the documentation and addressing of self-reported or QAU-generated deviations that may affect study quality.
• Compile data, organize contributing scientist reports, and assist in preparing the final study report so it accurately reflects study results.
• Maintain organized study files, track communications, and support archiving of data, documentation, protocols, specimens, and reports per GLP.
• Coordinate day-to-day study activities with technical staff, veterinary teams, and external partners (e.g., CROs if applicable).
• Contribute to internal tracking systems, meeting minutes, and status updates for the Preclinical Team.

Required Qualifications:

• Bachelor's degree in biology, neuroscience, biomedical engineering, animal science, or a related field.
• Minimum 1 year of experience in preclinical research support, study coordination, or project management (academic experience applies).
• Solid understanding of GLP regulations (21 CFR Part 58), basic knowledge of ISO 10993, and familiarity with in vivo animal studies.
• Strong organizational and project management skills with proven ability to manage timelines and multiple priorities.
• Excellent attention to detail and proficiency in data compilation, documentation, and Microsoft Office (or equivalent) tools.
• Experience working in or supporting animal research facilities with IACUC protocols.

Preferred Qualifications:

• Master's degree in biology, neuroscience, biomedical engineering, animal science, or a related field.
• Direct experience with neural device implantation studies or neurosurgical models.
• Background in a CRO or medical device preclinical setting.
• Familiarity with electronic data capture systems or GLP-compliant documentation platforms.

Additional Requirements and Competencies:

• Willingness to work in an animal research facility environment (with required training and PPE).
• Flexibility in schedule to support critical study timepoints.