The NINDS Topics in Clinical Research Seminar Series Presents, From Protocol to Results: Optimizing Clinical Trial Operations Through Effective Project Management
Please log on for the next Topics in Clinical Research on May 21st, 2025 via Microsoft Teams where we welcome Nichol McBee, MPH, ACRP-CP, Faculty Research Associate, Department of Neurology, JHU; Executive Director, BIOS Clinical Trials Coordinating Center (BIOS CTCC); Faculty Program Lead, JHU ICTR Trial Advisor Program (TAP); and Director, Johns Hopkins University Trial Innovation Center (JHU TIC) as she shares her vast insight that…
- Strategic project management drives clinical trial efficiency, compliance, and success;
- Clinical trials are expensive and complex - inefficiencies are costly and can delay lifesaving treatments; and
- Regulatory scrutiny and patient safety demand streamlined, well-managed operation.
with Q&A to follow!
Nichol McBee has been an integral part of the BIOS Clinical Trials Coordinating Center, a full-service academic research organization, since its inception over 25 years ago. Her expertise is in the management of clinical trials, specifically in the areas of protocol compliance, adverse events monitoring, serious adverse event reporting, follow-up and documentation of potential outcome events. As executive director, she has direct oversight of day-to-day operations and human resources, and she provides input into overall project forecasting and staff capacity needs. She also serves as the project administrator of the Johns Hopkins University Trial Innovation Center, an NIH/NCATS program award to develop, demonstrate, and disseminate innovations for clinical trial efficiency.
In addition to these leadership roles, Nichol is responsible for implementing and maintaining quality assurance and quality control systems by managing SOP production to ensure BIOS CTCC-managed trials are documented and reported in compliance with each protocol and the applicable regulatory requirements in a timely and correct manner. She has been a vital part of the BIOS CTCC program responsible for the FDA IND applications and the management of the Brain Hemorrhage Thrombolysis clinical trial program since 1995.