Posted 27 days ago
Clinical Study Operations Associate
AI Summary
Clinical Trial Operations Associate coordinates study startup, site management, and live-study monitoring for Beacon’s clinical studies, ensuring regulatory compliance and smooth site operations.
About this role
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 (including minimal weekend support hours), ensuring the highest quality standards and compliance with regulatory requirements.
Beacon's robust asynchronous work practices ensure a first-class remote work experience, we also have in-person office hubs located in Boston, New York, and Paris.
What success looks like:
- 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.
What you will bring:
- 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; additional languages are a bonus.
- 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.
Skills
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