Main point of Contact for over 30 studies. Interface with investigative trial sponsors relative to all procedures for trial start-up, implementation and completion and ensure site readiness for timely start of trials (i.e., make arrangements with outside vendors, ensure IRB approvals and delivery of needed equipment and study drug, confirm rater certifications, schedule and coordinate site visits, ensure staff training, verify accurate source development, completion of Feasibility Questioners) ·Prepare regulatory submissions such as: 510(k), technical files, design dossiers for new and modified devices.· Prepared and maintained over 30 ongoing studies for compliance with the FDA, IRB and sponsors requirements which includes IND Safety Reports, SAE Reports, protocol deviations, FDA 1572 forms NDA, ANDA and Annual Reports· Retained regulatory binders for over 50 completed clinical research trials· Performed QA of all regulatory documents for IRB, Sponsor and FDA audit readiness· Communicated study status to sponsors, PI's and clinical staff. Distributed all incoming regulatory documents to Study Coordinators and / or Investigators· Preserved Informed Consent Form files for clinicians, current studies, study coordinators use in screening process and prepared and maintained monthly monitor visits (CRA)· Worked with numerous platforms for Electonic Data Capture – Rave, Clinphone, TAO, IntraLinks and others as well as Interactive Web Response Systems (IWRS)· Review and maintenance of Financial Disclosure Forms· Management of trial drug – storage and disposal