Randall Morris

About Randall Morris

20 + year history in clinical research and regulatory affairs management, investigationsand auditing, and clinical care delivery with repeated success conducting successful,compliant, and ethical clinical research trials and managing regulatory affairs.I’m Randall Morris, a nurse executive with both MSN and BSN degrees and Certified Clinical Research Professional (CCRP) designation. My career began as an inpatient clinical RN in the federal facilities and local hospitals. Since 2005, I have progressed through Clinical Resesrch Nurse, Clinical Research Coordinator, FDA Investigator, and Regulatory Compliance Officer roles with multiple federal agencies, including DHHS, USPHS, NIH, NEI, and FDA.I bring a strong record of strategic planning for both pre/post market activities, site strategy and management, and staff training – leveraging my clinical study and FDA Officer background to assess regulatory pathways and develop streamlined solutions.My experience spans both sponsored and investigator initiated clinical research trials with extensive involvement in participant enrollment, care, and retention. As an Investigator, I lead concurrent regional, national, and multijurisdictional investigations and inspections within the biological and clinical bioresearch monitoring industry. As a Compliance Officer I recommended regulatory and legal actions against violators of the FD & C Act and the PHS Act, and prepared advisory correspondence – always with a strong focus on rapidly achieving compliance objectives.Areas of expertise: Clinical Program & Project Management Good Clinical Practice (GCP) Phase I, II, IV Research Trials Inspection, Auditing & Investigations Pre/Post Market Studies Regulatory & Legal Compliance (GxP/GMP/GCP/GLP/GTP/QSR ) Team Building & Staff TrainingI am on LinkedIn to grow my professional network and welcome new connections.You can also contact me directly: R••••••••@gmail.com

Experience

1. Inspection Readiness Advisor Senior Gcp Auditor

   Fdaqrc

   Jun 2025 — Present · US

   Serves as the company Leader/Subject Matter Expert (SME) for the company’s Inspection Readiness program. Additionally, performs a wide variety of audits including GCP Mock Inspections, internal audits, vendor quality audits, and Investigator Site Audits (ISA).

Education

• Duke University

  Master of Science Nursing, Clinical Research Management

  2010 — 2012

• Old Dominion University

  Bachelors of Science Nursing, Nursing

  2000 — 2003

• FDA

  FDA Advanced Training (2008-2018)– FDA Office of Regulatory Affairs University (ORAU)., Regulatory Affairs

  2008 — 2018