Kathleen A. Dastoli has 25 years of experience coordinating and managing Clinical Research Protocols through Phase IV for Corporate Sponsored, IND/IDE, and N.I.H. Grant Pharmaceutical and Device Studies. She has expertise in all aspects of the Clinical Research Process from Pre-Study activities through Close-Out, including: submitting required Regulatory Documents to the FDA and local authorities; designing Clinical Study Protocols; creating Informed Consent Forms, Database and Manual of Operating Procedures; selecting Research Sites; conducting Site Initiation Visits; monitoring and auditing Study activities and data; training all levels of study personnel including Principal Investigators, Research Coordinators, Ancillary Service Staff and Data Entry Staff; developing patient recruitment strategies; and submitting documents to the central and/or local Institutional Review Board, IRB, from Initial Approval through Close-Out .
Kathleen comes to Matrix Medical Devices from Cleveland Clinic where she served as Clinical Research Nurse Coordinator in Ophthalmology and Women’s Health. She also served as the Institute Representative for the Research Compliance, Research Education and Research Policy and Procedures Committees. She received advanced training in Clinical Research Monitoring. Kathleen most recently held the position of Project Manager of a National Multi-Centered Research Study.
Prior to Cleveland Clinic, Kathleen was Co-Owner and VP of Lake Medical Research, LLC for 7 years. This was a dedicated site serving Northeastern Ohio in multi-therapeutic areas of clinical research studies. In addition to the above listed activities, she also was responsible for marketing her business to obtain new study projects, contracting with physicians to fill the role of Principal Investigators (PI) and aid in budgeting and contracting. She has coordinated studies in the areas of Cardiovascular, Respiratory, Neurology, Orthopedics, Ophthalmology, Women’s Health, Infection and Immunology. She has also assisted the FDA with audits on multiple studies resulting in “No Action Indicated” (NAI).
Kathleen graduated from St. Thomas Hospital School of Nursing as a Registered Nurse. She is currently an active member of the Association of Clinical Research Professionals (ACRP).