Beth Carson Email & Phone Number

Experienced Clinical Research Director and Registered Nurse with a demonstrated history of working in the medical device/biotechnology industry, including the creation of Clinical Affairs departments. Skilled in U.S. Food and Drug Administration (FDA), Design Control, Clinical Affairs, Corrective and Preventive Action (CAPA), and Orthopedics. Strong research professional with GCP clinical study management including protocol development, budget development and timeline management, pre-clinical and clinical protocol development and management, site management, CRO/CRA management, developing data collection forms (paper and electronic), IRB/EC application process, extensive international travel, study monitoring, data cleaning and analysis, and study close out. Other areas of experience include the development, writing and management of CERs for EU technical files, inclusive of gap analysis for new EU regulation updates and up classification of products; abstract and manuscript development as well as administrative support of the patent development and contract writing.

Listed skills include Medical Devices, Clinical Affairs, Product Launch, Orthopedics, and 21 others.