Neuralink

Clinical Research Coordinator

Job Description

Posted on: 
January 21, 2023

As a Clinical Research 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.

Responsibilities

  • 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.

Job Requirements

  • Working knowledge of medical and scientific terminology.
  • Demonstrated communication and management skills.
  • Demonstrated problem-solving abilities and demonstrated tactfulness and diplomacy in communication, preferably in a medical setting.
  • Basic understanding of the clinical trial process.
  • Experience working collaboratively and effectively on a team.

Preferred Qualifications

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