Clinical Research Coordinator

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 Neuralink Clinical team is at the heart of an ecosystem that merges neuroscience, engineering, and medicine. We work to shape the future of brain-computer interface (BCI) technology through the planning, launch, and execution of groundbreaking human clinical trials. Our team is built on a foundation of excellence, aiming to uphold the highest standards of Good Clinical Practice (GCP) while redefining what’s possible and revolutionizing the way people interact with technology. Through strict compliance with ethical and regulatory protocols, we focus on ensuring the well-being of our trial participants while advancing the frontiers of neuroscience! Every day will bring fresh challenges and unprecedented opportunities to pioneer new approaches in the pursuit of our mission. From navigating regulatory pathways, designing trial protocols and documentation, and executing clinical trials, our team is instrumental in translating Neuralink’s BCI technology for use in people! 

Job Responsibilities and Description: 

As a Clinical Research Coordinator, you’ll work within Neuralink’s Clinical team. You will also help support the larger team at Neuralink responsible for clinical trial operational and regulatory activities. 

• 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
• Develop trial recruitment and other participant-facing materials
• Maintain and implement study documentation (e.g., SOP and CRF edits)
• Coordinate interactions and payments and manage communications with external vendors
• Support Neuralink clinical studies by ensuring adherence of trial plans to study protocols as well as ensuring compliance with regulations and standards for clinical research
• Maintain a working knowledge of and assure compliance with Good Clinical Practices, Federal Regulatory requirements, Risk-Based Approach to Monitoring, and Neuralink SOPs
• 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
• Assist internal teams with data reporting processes related to clinical trials

Certifications

• Opportunity to obtain your CCRA certification or equivalent (yes, we’ll pay for it!) 

Key Qualifications

• Evidence of exceptional ability in clinical study coordination
• Working knowledge of medical and scientific terminology
• Experience coordinating clinical trials or clinical research
• Demonstrated recruitment and screening potential participants
• Experience working collaboratively and effectively on cross functional teams
• Demonstrated problem-solving abilities
• Demonstrated tactfulness and diplomacy in communication, preferably in a medical setting

Preferred Qualifications 

• Experience running concurrent clinical studies
• Experience managing payments for clinical studies or vendors
• Experience maintaining investigator site files and/or trial master file systems
• Basic knowledge of Good Clinical Practice (ISO 14155), 21 CFR part 50, 54, 56, 812 and other applicable regulations

Pay Transparency:

Based on California law, the following details are for California individuals only:

California base salary range:  $87,804.88—$106,841.46 USDFor 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 you enter the organization (with the ability to gain more through time as you contribute).    Full-Time Employees are eligible for equity and benefits listed below in addition.

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; parental leave.
• Flexible time off + paid holidays.
• Equity + 401(k) plan.
• Commuter Benefits.
• Meals provided