Senior CRA

CoMind Technologies Limited

$100K — $120K *
US-AnywhereRemote in United States
Pharmaceuticals & Biotech
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • 5-7 years of clinical research experience, preferably in medical devices
  • Experience in sponsor-side clinical monitoring, both on-site and remote
  • In-depth understanding of GCP, ICH, and FDA regulations
  • Strong organizational and documentation skills for managing multiple relationships
  • Familiarity with EDC, eTMF, and CTMS tools

Responsibilities

  • Conduct comprehensive monitoring visits in adherence with GCP, ICH, and study protocols
  • Perform detailed data reviews and manage queries to ensure site performance and compliance
  • Identify, escalate, and mitigate site issues while supporting CAPA activities
  • Cultivate strong investigator site relationships, offering training and support
  • Prepare and manage IRB submissions and track approvals efficiently
  • Maintain high-quality Trial Master Files and support site activation processes
  • Leverage AI in operational tasks to enhance collaboration and innovation

Benefits

  • Company equity plan
  • Annual Unlimited PTO
  • Health insurance with 50% premium contribution
  • Dental insurance with 50% employer contribution
  • Vision insurance with 50% employer contribution
  • 401k plan featuring employer match up to 3%
  • Access to mental health resources
Full Job Description
This job is based remotely in the US, and is expected to work East Coast hours. CoMind can only accept applications residing in the current states: Colorado, Florida, Missouri, Texas, Washington State, Wisconsin. The Role The Clinical Team leads the deployment of CoMind'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 CoMind'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. Responsibilities: • Conduct qualification, initiation, interim, and close-out monitoring visits (on-site and remote) in accordance with GCP, ICH, the study protocol, and CoMind 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. Skills & Experience: • 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 Nice to have: • 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. Benefits: • Company equity plan • Annual Unlimited PTO • Health insurance plan - CoMind 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

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