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Beacon Biosignals is on a mission to revolutionize precision medicine for the brain. We are the leading at-home EEG platform supporting clinical development of novel therapeutics for neurological, psychiatric, and sleep disorders. Our FDA 510(k)-cleared Waveband EEG headband and AI algorithms enable quantitative biomarker discovery and implementation. Beacon’s Clinico-EEG database contains EEG data from nearly 100,000 patients, and our cloud-native analytics platform powers large-scale RWD/RWE retrospective and predictive studies. Beacon Biosignals is changing the way that patients are treated for any disorder that affects brain physiology. We are seeking a Clinical Trial Operations Associate to join us in our mission to make brain monitoring easily accessible, interpretable, and actionable. In this role, you will collaborate with clinical research sites, project teams, and internal stakeholders to support the deployment of Beacon’s devices in clinical studies. This role focuses on study startup, site management, and live-study monitoring, ensuring the highest quality standards and compliance with regulatory requirements.
Job Responsibility:
Collaborate with project teams to support study startup activities
Act as the primary point of contact for clinical sites, ensuring smooth operations and clear communication
Provide training to research sites on the use of Beacon’s devices and study protocols, ensuring proper device usage and data collection
Monitor project progress, ensuring adherence to timelines, protocols, and quality standards
Maintain compliance with Good Clinical Practice (GCP), International Conference on Harmonization (ICH) guidelines, and regulatory standards
Address operational issues promptly, escalating through tools like Zendesk and Asana for resolution
Provide actionable feedback from research sites to inform improvements in devices and workflows
Requirements:
Experience in clinical project management or clinical operations roles
Strong organizational and project management skills, with the ability to manage multiple responsibilities effectively
Excellent written and verbal communication skills in English
A proactive mindset with the ability to identify priorities and anticipate challenges
Meticulous attention to detail, ensuring accuracy in data collection and reporting
Familiarity with GCP, ICH guidelines, and clinical research regulatory requirements
A desire to learn more about analytics, statistics, machine learning, and clinical trials
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