This includes, but is not limited to: coordinating and maintaining regulatory activities, IRB submissions and ongoing IRB reporting responsibilities, screening and recruitment of study subjects, obtaining informed consent from subjects, assuring protocol adherence for required study procedures, timely and accurate completion of case report forms and related study documentation, coordination of study activities with Investigators, associated departments, staff and sponsor representatives, ongoing maintenance of all study materials, products and documents. TriMet annual pass (Hop Fastpass) for benefit eligible staff who work within the Portland Service Area (does NOT include Wilsonville, Newberg, Seaside, Hood River, Washington State, or Medford).