Supported the GE Medical and Clinical Affairs Team with the Clinical Monitoring of medical device research studies at domestic and international research institutions and hospitals.
Visits performed included, but were not limited to:
- Pre-Study Site Qualification Visits
- Site Initiation Visits
- Interim Monitoring Visits
- Site Closure Visits
- Site/Sponsor Audits, and Regulatory Audit Support and Preparation
Directly responsible for the management of study execution and documentation at the site level, coordinating with data and image management CROs, EC/IRB reporting, ensuring adherence to GCPs and all regulatory requirements, and directly interfacing with physicians, researcher...