Clinical Trial Coordinator

Regulatory      ·     Fremont, CA    ·    Full time

As a Clinical Trial Coordinator, you’ll work under the direction of the Clinical Trial Manager and within Neuralink’s Clinical team. You will also help support the team responsible for clinical trial operational and regulatory activities. 

About you

• Self driven; able to initiate and work independently.
• Effective communicator; able to present information to staff and potential trial participants.
• Positive attitude: ability to work well with others.
• Adaptable to change and willing to accept added responsibilities and accountability.
• Ability to meet deadlines with accuracy and efficiency.
• Great attention to detail and organizational skills.
• Effective multitasking skills.
• Ability to work in a dynamic environment and effectively and collaboratively in a cross-disciplinary team. 

Key Qualifications

• Understanding of the Clinical Trial process from beginning to end 
• Experience with medical device clinical studies 
• Work collaboratively and effectively with investigators, research site staff, and Neuralink teammates
• Working knowledge of medical and scientific terminology
• Demonstrated communication and management skills
• Demonstrated problem-solving abilities in managing clinical studies and demonstrated tactfulness and diplomacy in communicating with investigators, participants, and study coordinators

Preferred Qualifications 

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

Examples of concrete duties

• 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.

What we offer:

• An opportunity to change the world and work with some of the smartest and the 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; parental leave.
• Flexible time off + paid holidays.
• Equity + 401(k) plan.
• Commuter Benefits.
• Meals provided.

Neuralink provides equal opportunity in all of our employment practices to all qualified employees and applicants without regard to race, color, religion, gender, national origin, age, disability, marital status, military status, genetic information or any other category protected by federal, state and local laws.  This policy applies to all aspects of the employment relationship, including recruitment, hiring, compensation, promotion, transfer, disciplinary action, layoff, return from layoff, training and social, and recreational programs. All such employment decisions will be made without unlawfully discriminating on any prohibited basis.

Tagged as: BCI, Neuroscience