СШАSenior CRA
3 нед. назад
130k–145k USD / годСШАSeniorRemote
clinical trial monitoringgcpichsource data review
Lead site monitoring and support clinical studies for neuromonitoring technology deployment in hospitals.
Обязанности
- The Clinical Team leads the deployment of 's technology into hospital environments for the first time, managing clinical sites, supporting device installations, and ensuring the smooth execution of clinical studies in partnership with clinicians.
- As Senior CRA, you will own site monitoring across 's clinical programme, with responsibility spanning on-site and remote visits, in-house operations support, and study oversight. This is a hands-on role with real breadth: you will be the primary relationship owner at investigator sites while also contributing to trial management and IRB coordination internally.
- Please note that this role will require approximately 50% travel, depending on study needs.
- Conduct qualification, initiation, interim, and close-out monitoring visits (on-site and remote) in accordance with GCP, ICH, the study protocol, and SOPs
- Perform source data review and verification, manage data query resolution, and evaluate site performance, protocol adherence, and enrollment progress
- Identify and escalate site issues, deviations, and risks; support CAPA development and inspection and audit readiness activities
- Build and maintain strong relationships with investigator sites, providing training, guidance, and support to ensure study quality and continuity
- Prepare, submit, and track IRB maintenance submissions including continuing reviews, amendments, and safety updates, coordinating directly with central IRBs to ensure timely approvals
- Maintain Trial Master File quality, support regulatory submissions and site activation activities, and manage IP logistics and accountability documentation
- AI is fundamental to our culture -- it's not just a tool, but a core part of how we work, collaborate, and innovate. We expect all team members to embrace AI in their daily work and continuously find new ways to use it effectively.
Требования
- Substantial clinical research experience, with a background in medical devices preferred
- Extensive on-site and remote monitoring experience as a sponsor-side CRA
- Strong working knowledge of GCP, ICH, FDA, and applicable global clinical research regulations
- Proven organisational and documentation skills, with the ability to manage multiple site relationships and responsibilities simultaneously
- Proficiency with EDC, eTMF, CTMS, and standard office software
Будет плюсом
- Experience with early feasibility studies, NSR studies, or IDE-regulated frameworks
- Familiarity with neurology, neurocritical care, TBI, or ICU-based clinical settings
- Experience coordinating IRB submissions and managing regulatory documentation at a sponsor level.
Условия
- Company equity plan
- Annual Unlimited PTO
- Health insurance plan - contributes 50% to the monthly premium (with the Blue Cross Network)
- Dental insurance (50% Employer Contributions to individual policy)
- Vision insurance (50% Employer Contributions to individual policy)
- 401k plan with an employer match up to 3%
- Mental health resources
Другое
- This job is based remotely in the US, and is expected to work East Coast hours. can only accept applications residing in the current states: Colorado, Florida, Missouri, Texas, Washington State, Wisconsin.
- At , we are developing a non-invasive neuromonitoring technology that will result in a new era of clinical brain monitoring. In joining us, you will be helping to create cutting-edge technologies that will improve how we diagnose and treat brain disorders, ultimately improving and saving the lives of patients across the world.