Kathleen Morgan

Experience

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  Cardiovascular Research Foundation

  Jan 1993 - Jan 2008

  Clinical Research Coordinator/Associate

  Study coordinator for a large group of interventional cardiologists. Communicated with patients to collect data and source documents for a variety of coronary, carotid, renal, and iliac stent protocols. Documented findings on Case Report Forms and maintained FDA Regulatory Documents. Supported our sponsored annual TCT international conference. Remained a CRC when CRF moved from DC to New York to establish a Contract Research Organization (CRO). Collected data on patients enrolled in cardiovascular drug and device studies. In addition to collecting Major Adverse Cardiac Events (MACE), I obtained source documents and reported Serious Adverse Events (SAEs) and changes in medications according to protocol. I later trained and worked as a CRA in the data coordinating center. Show less

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  Carient Heart & Vascular

  Jan 2009 - Nov 2015

  Director of Research

  Initiated the clinical research program for the Carient cardiology practice. Recruited, trained and supervised clinical research coordinators and developed standard operating procedures (SOP) to conduct clinical research in an outpatient setting. Developed relationships with multiple sponsors in the research industry. Arranged site qualification visits for many exciting cardiovascular trials. Ensured all investigators and coordinators are compliant with ICH guidelines and GCP training. Negotiated contracts and budgets, compiled regulatory documents, and prepared for site initiation, routine monitoring and close out visits. Directly involved in the recruitment, evaluation and treatment of research subjects for Phase II-IV clinical trials in a cardiology setting. Daily responsibilities included clinical assessments, screening, drug accountability and compliance, maintenance of source documentation, and case report forms. Close interaction with investigators and research staff to ensure protocol compliance and proper documentation. Consented subjects according to SOP, processed labs according to protocols, conducted accurate data entry and adverse event reporting. Show less

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  Inova Health System

  Nov 2015 - Jan 2020

  Director of Clinical Trials

  Manage, educate and support the IHVI clinical trials team ensuring opportunities for professional development. Facilitate all phases of clinical trials from site feasibility through close out. Collaborate with sponsors and investigators to determine feasibility for future trials. Promote training and Good Clinical Practice (GCP) certification for new investigators in the Inova Medical Group. Communicate across multi-disciplinary departments to ensure protocol compliance. Instrumental in the growth of this research program by expanding to 8 satellite clinics and hospital sites within the Inova system. Experience with investigator-initiated studies as well as sponsored drug, device and biomarker trials. Additional responsibilities include:• Leadership discussion with other Inova research department managers and directors to collaborate on best practices.• Recruiting, training and supervision of clinical research coordinators.• Staff education and training for adherence to organizational and sponsor requirements and to promote professional growth. • Contract and budget negotiations using Coverage Analysis.• Development of Standard Operating Procedures and Standard Work Documents to conduct Clinical Research.• Regular meetings with staff and Investigators to ensure protocol compliance and documentation and to discuss study related activities and corrective action plans. Show less

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  Virginia Department of Health

  Oct 2020 - Oct 2022

  COVID Case Investigator
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  Idorsia Pharmaceuticals Ltd

  Mar 2022 - now

  Clinical Research Consultant
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  Carient Heart & Vascular

  Sept 2022 - now

  Clinical Research Director