As a Clinical Research Associate, you’ll work under the direction of the Clinical Trial Manager and within Neuralink’s Clinical team. You will also help train and support the team responsible for clinical trial operational and regulatory activities.
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.
Understanding of the Clinical Trial process from beginning to end
Work collaboratively and effectively with investigators, research site staff, and Neuralink teammates
Working knowledge of FDA regulations related to clinical studies
Working knowledge of medical and scientific terminology
Demonstrated communication skills
Demonstrated problem-solving abilities in leading clinical trial monitoring visits and demonstrated tactfulness and diplomacy in communicating with investigators, participants, and study coordinators
Thorough knowledge of Good Clinical Practice (ISO 14155), 21 CFR part 50, 54, 56, 812 and other applicable regulations
Understanding of Class III implantable neuromodulation devices
Examples of concrete duties
Support Neuralink clinical studies, including site qualification and initiation, monitoring, and close-out activities as well as ensuring compliance with regulations and standards for clinical research.
Conduct clinical trial monitoring visits to review and assure the rights, welfare, and safety of study participants are protected, ensure integrity of clinical data and adherence to procedures through review of source documents and regulatory documents.
Support site audits and site audit preparation in anticipation of site inspections.
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, closures.
Help develop and implement SOPs for clinical trials and related activities.
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.
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.