Liz Wool, RN, BSN, CCRA, CMT
President and CEO

Liz Wool possesses 24 years in the product development industry inclusive of positions in biotech and pharmaceutical companies, investigational sites, CROs, and academia. This experience includes drugs, biologics and medical device clinical research.

She has been invited faculty for federal agency conferences, notably,  Office of Human Research Protections (OHRP) regional educational events (2010), and the Office of Research Integrity (ORI) Quest for Excellence Conference (2011).  Further, she is an expert speaker at industry meetings on CRO-Vendor management, clinical quality systems and Good Clinical Practices (GCP) for numerous professional organizations and industry training providers including the Association of Clinical Research Professionals (ACRP), Drug Information Association (DIA), IIR Partnerships in Clinical Trials, Society of Quality Assurance (SQA), Society of Research Administrators (SRA), ExL Pharma Conferences, FDANews.  She has also been a faculty member for the Association of Clinical Research Professionals (ACRP), teaching the CRA and CRC Certification Exam Review Courses. Further, she supports the National Institutes of Health (NIH) as a Peer Reviewer for monitoring and auditing contracts. She served as a Metric Champions Consortium (MCC) representative at the FDA-CTTI Site Metrics for Study Start-Up meeting in 2011 and is a faculty member for the Metrics  Champion Consortium Institute.

Liz's expertise is unique in that she has held positions as a Research Nurse at Johns Hopkins Hospital in Baltimore, Maryland, site monitor (CRA), CRA manager, study manager, Sr. Manager, West Coast Learning and Development, Head, Clinical Research Training,  as well as, director-level positions in Clinical Compliance and Clinical Operations.  This experience has been obtained through positions at Gilead, Quintiles, Johnson and Johnson Pharmaceutical Research and Development, Scios and The Henry M. Jackson Foundation. This comprehensive experience provides her with the ability to understand both the conduct and management of clinical trials from the site and sponsor perspective thereby providing consulting support that is global and comprehensive in nature. Her experience in quality systems development and management coupled with her experience with internal and external regulatory inspections (MHRA, FDA) and CAPA 'solutions' for her assigned departments influences the global focused 'solutions' that QD-Quality and Training Solutions, Inc. provides to our clients.

She has held faculty appointment at the University of California, Berkeley and held Advisory Board appointments to the Quality and Compliance and Clinical Research Conduct and Management certificate programs.   She taught Good Clinical Practices (GCP) to students in the following certificate programs: Project Management, Regulatory Affairs, Clinical Research Conduct and Management, and, Quality and Compliance.

She volunteers her time to ACRP by serving on the ACRP, Board of Trustees, ACRP Monitor magazine, and Regulatory Affairs Committee.  Liz’s publications include:

• Good Training Practice 101: A Primer for Employee Training Plans, June, 2008, Monitor magazine, for the Association of Clinical Research Professionals.
  
  
• Investigator Meetings: Focus on Protocol Execution Performance, February, 2011, (Martin, Shabe, Wool), Monitor magazine, for the Association of Clinical Research Professionals.
  
  
• Intertwining Quality Management Systems with Metrics to Improve Trial Quality, August 2012, Monitor magazine, for the Association of Clinical Research Professionals.