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[Remote] Clinical Research Associate / Clinical Ops Coordinator

10/4/2025

San Francisco

Note: The job is a remote job and is open to candidates in USA. iSono Health is a dynamic medical device company focused on transforming breast care through innovative technologies. They are seeking a Clinical Research Associate / Clinical Ops Coordinator to manage clinical trials, ensuring data accuracy and smooth operations in a fast-paced environment.

Responsibilities
• Conduct site visits (initiation, monitoring, close-out) and keep sites aligned with protocol and GCP.
• Verify source data and help resolve queries quickly.
• Provide training and serve as a go-to for site staff.
• Enter and review clinical data in EDC.
• Spot issues and inconsistencies early and follow through to resolution.
• Help keep data flowing on time and accurate.
• Support study start-up (reg docs, IRB/EC submissions, site set-up).
• Maintain study files and trackers (eTMF, logs, spreadsheets).
• Track enrollment, timelines, and key milestones.
• Jump in wherever needed — from vendor coordination to preparing reports for leadership.

Skills
• 2–4 years in clinical research (CRA, coordinator, or clinical ops)
• Strong knowledge of GCP and basic regulatory requirements
• Comfortable with EDC, eTMF, and Excel/Google Sheets
• Sharp eye for detail and love of clean data
• A problem-solver who doesn’t wait to be told what to do
• Excited by startup life — resourceful, adaptable, and collaborative
• Experience in oncology, imaging, or medical devices
• Prior exposure to risk-based monitoring
• Familiarity with dashboards, trackers, or clinical ops tech

Company Overview
• iSono Health develops an AI platform for accessible and personalized breast health monitoring It was founded in 2015, and is headquartered in San Francisco, California, USA, with a workforce of 2-10 employees. Its website is http://www.isonohealth.com/.

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