Two years’ experience with clinical responsibilities for medical device companies with Class II devices – including an in-vitro molecular diagnostics device to detect infectious disease and a dermatological radiofrequency device that ablates nerves to reduce forehead wrinkles. Qualifications include leading a recruitment effort to secure 65 patients in 3 months across 5 sites, experience conducting and monitoring GCP phase I & phase IV clinical studies, IRB submission & coordination activities and the supporting regulatory activities associated with such trials. Transferable skills from pre-clinical post-doctoral work consist of writing and securing a 2-year grant from the NIH for $200,000, vendor management during a laboratory manager role, and publishing as first author in peer-reviewed journals. Valuable abilities obtained from practicing as a physician include critical thinking and analytical skills to solve complex problems, establishing and maintaining long-term relationships, and experience interfacing with other medical professionals in a myriad of therapeutic areas. Working knowledge of Python, Microsoft Word, Outlook, Excel, PowerPoint and Electronic Data Capture systems like Clin Plus Data Management and Aptiv Solutions. Familiar with Trial Master files, CTMS systems, Basecamp Project Management and Redcap Data Capture Management. Vendor and CRO experience with Aptiv Solutions, VWR, Fisher Scientific and Praxair. Spanish written and oral proficiency. Dual citizen Italy / US.

Highlights:

• monitoring
• GCP
• clinical research
• Seattle
• diagnostics
• medical device
• vendor
• in-vitro