Company Description:
We are creating the future of brain-computer interfaces: building devices now that have the potential to help people with paralysis regain mobility and independence and invent new technologies that could expand our abilities, our community, and our world.
Team Description:
The Clinical Team is responsible for the development, implementation, execution, and oversight of Neuralink’s human clinical trial operations. We build and manage key relationships between internal Neuralink teams and external organizations such as study sites, research partners, regulatory bodies, and other entities essential to successfully carrying out human clinical trials.
Job Description and Responsibilities:
As a Clinical Research Associate, you'll play a crucial role in pioneering groundbreaking clinical studies! Your work will directly contribute to the planning, execution, and success of innovative trials, from the initial phases of study setup to hands-on clinical monitoring and site management. You'll be visiting sites both in-person and remotely to ensure protocol and regulatory compliance, tackle safety event management, and maintain essential documentation. Collaborating closely with a passionate, cross-functional team, as well as external partners, you'll be at the forefront of Neuralink's mission to push the boundaries of what’s possible in clinical research. Additional job responsibilities will include:
- Conducting qualification, initiation, monitoring, and closeout visits at research sites in compliance with the approved protocols and applicable regulations
- Verifying adequate investigator qualifications, training and resources, including facilities, laboratories, equipment, and staff
- Verifying medical record and source documentation against case report form (CRF) data, including informing the site staff of any entry errors, ensuring good documentation (GDP) practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP, and applicable regulatory requirements
- On-site and virtual/remote monitoring activities with a risk-based monitoring approach (including centralized data review) to identify site deviations/deficiencies and corrective/preventive actions to bring a site back into compliance and mitigate risks moving forward
- Assisting in regulatory document write-up and reviews
- Organizing and submitting IRB/EC submissions and applicable regulatory documentation with follow-through to ensure successful outcomes
- Amending clinical study documents (ICF, CRFs, Monitoring Plan, etc…) as needed and helping clinical sites with institutional review board submission as necessary
- Reviewing and verifying adverse events, serious adverse events, concomitant medications and corresponding illnesses to confirm accurate data reporting in accordance with protocol
- Assessing the clinical research site's patient recruitment and retention success and offering suggestions for improvement as well as helping with Sponsor recruitment activities
- Completing monitoring reports and follow-up letters, which includes providing summaries of the significant findings, deviations, deficiencies, and recommended actions to secure compliance
- Contributing to the review of consent form language for consistency across protocols
Required Qualifications:
- Bachelor's degree in life sciences or related field
- Minimum of 5 years of experience working in clinical trials with 3 years as a Clinical Research Associate
- Strong understanding of GCP, FDA, and ICH guidelines, regulations, and compliance requirements (e.g., 21 CFR 812, ISO14155)
- Proven ability to manage multiple tasks, prioritize workload effectively, and meet deadlines in a fast-paced environment
- Excellent interpersonal, communication, and organizational skills
- Ability to travel domestically and internationally, as required, up to 50%
Preferred Qualifications:
- Advanced degree in life sciences or related field
- Significant experience in medical device studies
- Certification as a Clinical Research Professional (CCRP) or equivalentProficiency in Microsoft Office Suite and familiarity with electronic data capture (EDC) systems
- Experience working in a fast-paced medical device startup environment
- Experience working in neuromodulation, surgical robotics, or another Class III implantable device
For Full-Time Employees, your compensation package will include two major components: salary and equity. Guidance on salary for this role will be determined according to the level at which you enter the organization, with the ability to gain more over time as you contribute. In addition, Full-Time Employees are eligible for the following benefits listed below.
What We Offer:
- An opportunity to change the world and work with some of the smartest and 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
- Paid holidays
- Commuter benefits
- Meals provided
- Equity + 401(k) plan *Temporary Employees & Interns excluded
- Parental leave *Temporary Employees & Interns excluded
- Flexible time off *Temporary Employees & Interns excluded
Multiple studies have found that a higher percentage of women and BIPOC candidates won't apply if they don't meet every listed qualification. Neuralink values candidates of all backgrounds. If you find yourself excited by our mission but you don't check every box in the description, we encourage you to apply anyway!
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.
If you need a reasonable accommodation at any point in the interview process, please let us know. Reasonable accommodations are modifications or adjustments to the application or hiring process that would enable you to fully participate in those processes. Examples of reasonable accommodations include but are not limited to:
- Documents in alternate formats or read aloud to you
- Having interviews in an accessible location
- Being accompanied by a service dog
- Having a sign language interpreter present for the interview
