Job Description
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 β’ Conduct site visits (initiation, monitoring, close-out) and keep sites aligned with protocol and GCP. β’ Verify source data and help resolve queries quickly. β’ Provide training and serve as a go-to for site staff. β’ Enter and review clinical data in EDC. β’ Spot issues and inconsistencies early and follow through to resolution. β’ Help keep data flowing on time and accurate. β’ Support study start-up (reg docs, IRB/EC submissions, site set-up). β’ Maintain study files and trackers (eTMF, logs, spreadsheets). β’ Track enrollment, timelines, and key milestones. β’ Jump in wherever needed β from vendor coordination to preparing reports for leadership. Skills β’ 2β4 years in clinical research (CRA, coordinator, or clinical ops) β’ Strong knowledge of GCP and basic regulatory requirements β’ Comfortable with EDC, eTMF, and Excel/Google Sheets β’ Sharp eye for detail and love of clean data β’ A problem-solver who doesnβt wait to be told what to do β’ Excited by startup life β resourceful, adaptable, and collaborative β’ Experience in oncology, imaging, or medical devices β’ Prior exposure to risk-based monitoring β’ Familiarity with dashboards, trackers, or clinical ops tech Company Overview β’ 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 Apply tot his job