Melissa Egbert
- Role
- Clinical Trial Manager at Natera
- Location
- Redwood City, CA, US
- LinkedIn followers
- 500 followers
About Melissa Egbert
I am passionate about advancing the maternal fetal medicine field with quality research…
Experience
Clinical Trial Manager
Nov 2015 — Present
Responsible for managing day-to-day operation activities associated with the execution of prenatal clinical trials. Manage internal clinical study team to ensure trials are completed within expected timelines, within budget, and in compliance with SOPs, regulations, and GCP guidelines. Manage investigator & site selection, study initiation, enrollment, data collection, and study reports for ongoing and new clinical trials. Manage CRO relationships, RFPs, contracts, and work execution monitoring. Create, submit, and maintain study protocols and regulatory documentation for ongoing research at Natera. Assist in creation, submission, and maintenance of IRB approval and regulatory documentation for participating research sites. Facilitate logistics of sample and data flow from external clinics and internally for R&D, & PDO studies. Write and optimize clinical trial SOPs and ensure compliance of staff and study teams Develop and implement clinical monitoring plans, and oversee study monitoring procedures.
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