Portrait photo

Shelly Simpson

Director, Clinical Monitoring Research Program

Biography

Shelly Simpson is an innovative, experienced leader, manager and project manager specializing in full-cycle clinical trials management and clinical trials monitoring domestically and internationally. During her career, she has assumed progressively more responsible and complex roles in managing clinical research teams that were integrally involved in some of the greatest healthcare threats to our nation, including the COVID pandemic and Ebola crisis in Africa.   

Simpson has consistently delivered timely, high-quality clinical trials monitoring strategies and management of other project related deliverables. Her teams ensure compliance with study protocols and ICH-GCPs, CFR title 21 FDA parts 11, 50, 54, 56, 312 and 812, DHHS and international regulations, and NIH policies and fulfillment of project objectives. She provides leadership and guidance with colleagues, clinical sites, principal investigators and customers related to all applicable regulations, GCPs, contract requirements best practices for managing protocol compliance. 

Simpson and her team were recognized by NIH and FNL leadership for consistently delivering timely, high-quality clinical trials monitoring strategies and management. They were part of the team that received a 2020 NIH’s Director’s Award, for the DCR/NIAID PALM Consortium, and two FNL Outstanding Achievement Awards in 2020, for outstanding support to NIAID/FDA Inspection for PALM EBOLA study in the Democratic Republic of the Congo and for critical participation in the execution of the COVID master platform protocol. Simpson was one of the five CMRPD recipients of the 2020 FNL President’s Award for contributing to the establishment of the international remdesivir COVID clinical trial, travelling to set up sites in South Korea and Japan even as Americans abroad in the early days of the pandemic were rushing home to the United States.  

Simpson has a BA in political science from St. Mary’s College of Maryland and a master’s degree in science technology management, with a concentration in biotechnology, at the University of Maryland.