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Clinical Trial Coordinator

Neuralink -   Fremont, California, United States   CA

Posted 7 days ago

Salary: Not Disclosed

Tags: clinic , ca , clinical ,

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As a Clinical Trial 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. 

About you

<li style="font-weight: 400;"><span style="font-weight: 400;">Self driven; able to initiate and work independently.

<li style="font-weight: 400;"><span style="font-weight: 400;">Effective communicator; able to present information to staff and potential trial participants.

<li style="font-weight: 400;"><span style="font-weight: 400;">Positive attitude: ability to work well with others.

<li style="font-weight: 400;"><span style="font-weight: 400;">Adaptable to change and willing to accept added responsibilities and accountability.

<li style="font-weight: 400;"><span style="font-weight: 400;">Ability to meet deadlines with accuracy and efficiency.

<li style="font-weight: 400;"><span style="font-weight: 400;">Great attention to detail and organizational skills.

<li style="font-weight: 400;"><span style="font-weight: 400;">Effective multitasking skills.

<li style="font-weight: 400;"><span style="font-weight: 400;">Ability to work in a dynamic environment and effectively and collaboratively in a cross-disciplinary team.&nbsp;

Key Qualifications

<li style="font-weight: 400;"><span style="font-weight: 400;">Understanding of the Clinical Trial process from beginning to end&nbsp;

<li style="font-weight: 400;"><span style="font-weight: 400;">Experience with medical device clinical studies&nbsp;

<li style="font-weight: 400;"><span style="font-weight: 400;">Work collaboratively and effectively with investigators, research site staff, and Neuralink teammates

<li style="font-weight: 400;"><span style="font-weight: 400;">Working knowledge of medical and scientific terminology

<li style="font-weight: 400;"><span style="font-weight: 400;">Demonstrated communication and management skills

<li style="font-weight: 400;"><span style="font-weight: 400;">Demonstrated problem-solving abilities in managing clinical studies and demonstrated tactfulness and diplomacy in communicating with investigators, participants, and study coordinators

Preferred Qualifications&nbsp;

<li style="font-weight: 400;"><span style="font-weight: 400;">Thorough knowledge of Good Clinical Practice (ISO 14155), 21 CFR part 50, 54, 56, 812 and other applicable regulations

<li style="font-weight: 400;"><span style="font-weight: 400;">Experience coordinating clinical trials or research.&nbsp;

<li style="font-weight: 400;"><span style="font-weight: 400;">CCRA certification

Examples of concrete duties

<li style="font-weight: 400;"><span style="font-weight: 400;">Support Neuralink clinical studies by ensuring adherence to study protocols as well as ensuring compliance with regulations and standards for clinical research.&nbsp;&nbsp;

<li style="font-weight: 400;"><span style="font-weight: 400;">Serve as the first line of contact with interested clinical trial participants.&nbsp;

<li style="font-weight: 400;"><span style="font-weight: 400;">Establish and maintain relationships with community partners and patient advocacy groups.

<li style="font-weight: 400;"><span style="font-weight: 400;">Assist Community Engagement team with trial recruitment activities.&nbsp;

<li style="font-weight: 400;"><span style="font-weight: 400;">Review study specific materials and extract relevant data.&nbsp;

<li style="font-weight: 400;"><span style="font-weight: 400;">Develop and implement SOPs for clinical trials and related activities.

<li style="font-weight: 400;"><span style="font-weight: 400;">Collect and complete regulatory documents for the Sponsor and Institutional Review Board (IRB) as needed.

<li style="font-weight: 400;"><span style="font-weight: 400;">Provide regulatory assistance when needed including, but not limited to safety reports, SAE reporting, additional submissions, approvals, and closures.

<li style="font-weight: 400;"><span style="font-weight: 400;">Support Clinical Research Associate(s) to conduct study monitoring visits and prepare for site audits.

<li style="font-weight: 400;"><span style="font-weight: 400;">Maintain a working knowledge of and assure compliance with Good Clinical Practices, Federal Regulatory requirements, Risk-Based Approach to Monitoring, and Neuralink SOPs.

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