Description
This is a small, virtual device company focusing on 3D ultrasound imaging for breast cancer diagnostics.Role:
- Reports directly to the Chief Medical Officer
- Monitors clinical studies and sites for adherence to protocol, GCP and Monitoring Plan; ensures timely enrollment against the operational plan
- Prepares study related documents including Informed Consent Forms (ICFs), draft source documents, Core Laboratory Work Instructions, Study Reference Binders, and Case Report Forms (CRF)
- May serve as primary contact for multiple clinical sites
- Tracks essential documents; files documents in Trial Master File (TMF)
- CRO/vendor management duties
- Assists in development of site budgets and facilitates routine site budget negotiations
Requirements:
- B.S. degree or something equivalent
- 4+ years experience in the clinical trial industry
- 2+ years clinical field monitoring experience
- MUST have worked directly on an imaging study previously; or prior work experience in a Core Lab or imaging CRO
- Clinical trial experience with medical devices
- Ability to travel domestically 50-60%