What are the responsibilities and job description for the Clinical Research Associate position at Neuralink?
About Neuralink :
We are creating devices that enable a bi-directional interface with the brain. These devices allow us to restore movement to the paralyzed, restore sight to the blind, and revolutionize how humans interact with their digital 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 :
Preferred Qualifications :
Pay Transparency :
The following details are for Texas individuals only.
Texas Pay Transparency
67,000-$102,000 USD
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 :
Salary : $67,000 - $102,000
