Clinical Research Coordinator

• Support Neuralink clinical studies by ensuring adherence to study protocols as well as ensuring compliance with regulations and standards for clinical research.  
• Serve as the first line of contact with interested clinical trial participants.
• Establish and maintain relationships with community partners and patient advocacy groups.
• Assist Community Engagement team with trial recruitment activities.
• Review study specific materials and extract relevant data.
• Develop and implement SOPs for clinical trials and related activities.
• Collect and complete regulatory documents for the Sponsor and Institutional Review Board (IRB) as needed.
• Provide regulatory assistance when needed including, but not limited to safety reports, SAE reporting, additional submissions, approvals, and closures.
• Support Clinical Research Associate(s) to conduct study monitoring visits and prepare for site audits.
• Maintain a working knowledge of and assure compliance with Good Clinical Practices, Federal Regulatory requirements, Risk-Based Approach to Monitoring, and Neuralink SOPs.

• Working knowledge of medical and scientific terminology.
• Demonstrated communication and management skills.
• Demonstrated problem-solving abilities and demonstrated tactfulness and diplomacy in communication, preferably in a medical setting.
• Basic understanding of the clinical trial process.
• Experience working collaboratively and effectively on a team.

Preferred Qualifications

• Experience with clinical studies.
• Basic knowledge of Good Clinical Practice (ISO 14155), 21 CFR part 50, 54, 56, 812 and other applicable regulations.
• Experience coordinating clinical trials or research.