Senior Clinical Research Associate - (Rockville, MD)

Piper Clinical Solutions is seeking a driven Senior Clinical Research Associate to support a growing biomedical company with medical device product development testing projects in Rockville, MD. Responsibilities for the Senior Clinical Research Associate: Overall management for medical device studies from conception to closeout including monitoring, regulatory, quality assurance, communication with essential study personnel and reporting activities. Development of study documents: clinical study protocols (CSP’s), informed consent documents (ICD’s), case report forms (CRF’s) forms and other study documents Regulatory submission oversight and tracking through the Institutional Review Board (IRB) & Food and Drug Administration (FDA) including communication with the IRB