Clinical Research Associate / Clinical Ops Coordinator
Overview iSono Health is a dynamic and rapidly growing early clinical-commercial stage medical device company dedicated to saving lives and transforming care through innovative robotics, AI, and 3D ultrasound technologies. At iSono Health, we're pioneering a new era of breast care. We believe every woman deserves access to fast, affordable, and comfortable screenings. That's why we developed ATUSA, the world's first AI-powered platform with a point-of-care, automated 3D ultrasound system. To succeed here, you need to think like an entrepreneur, act like a leader, and execute with precision. We value individuals who take initiative, embrace challenges, and are excited to wear multiple hats. Creativity, resilience, and a commitment to excellence are essential as we push the boundaries of what’s possible in healthcare. Our work is exciting because it’s meaningful. Together, we’re empowering women to take control of their health by expanding access to potentially lifesaving ultrasound technology. If you’re passionate about making a difference and ready to be part of a nimble, scrappy team that values impact over hierarchy, iSono Health is the place for you. At iSono Health, success isn’t just about the work—it’s about the mindset. We’re a small but mighty team of dedicated individuals driven by a shared mission: revolutionizing women’s health and making a profound impact for patients and clinicians. With big ambitions and innovative plans, we thrive in a fast-paced, dynamic environment where every team member owns what they build. Join us in transforming healthcare and be part of a team where every voice matters, every idea counts, and every action contributes to a greater purpose.
About the Role
We’re looking for a roll-up-your-sleeves clinical research professional who can bridge CRA site monitoring, data entry/quality checks, and day-to-day clinical operations. In a startup environment, no two days look the same — one day you’ll be at a site monitoring source documents, the next you’ll be troubleshooting an EDC query, and the next you’ll be helping track enrollment or prep for a regulatory submission. This role is for someone who thrives in a fast-moving, hands-on environment and wants to make an impact by keeping trials running smoothly, data clean, and operations on track. What You’ll Do
- Conduct site visits (initiation, monitoring, close-out) and keep sites aligned with protocol and GCP.
- 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.
- Clinical Ops Oversight
- 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.
What You Bring
- 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.
Bonus Points
- Experience in oncology, imaging, or medical devices.
- Prior exposure to risk-based monitoring.
- Familiarity with dashboards, trackers, or clinical ops tech.
Why Join Us
You’ll be at the heart of a small, mission-driven team pushing forward clinical innovation. We offer the chance to wear multiple hats, learn across functions, and see the direct impact of your work on study success. Apply tot his job Apply To this Job