Posted 7mo ago

Clinical Research Associate / Clinical Ops Coordinator

@ iSono Health
United States
RemoteContract
Responsibilities:Site monitoring, Data entry, Study startup
Requirements Summary:2–4 years in clinical research; strong GCP knowledge; comfortable with EDC, eTMF, and Excel/Google Sheets; detail-oriented; startup-friendly.
Technical Tools Mentioned:EDC, eTMF, Excel, Google Sheets
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Job Description

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

        Site Monitoring & Support

      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.

        Data Entry & Quality

      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.