Karen Lane, CCRP
Assistant Professor of Neurology, Johns Hopkins University Deputy Director, BIOS Clinical Trials Coordinating Center Director, Multicenter Study Operations Training Program, ICTR MPI, Johns Hopkins University Trial Innovation Center
Johns Hopkins University, BIOS Clinical Trials Coordinating Center
Karen Lane is co-founder of the Johns Hopkins University (JHU) BIOS Clinical Trials Coordinating Center. She played a key role in launching the JHU Trial Innovation Center, one of three US-centers of excellence in the NCATS-sponsored Trial Innovation Network. Her work centers on applying lean management principles to streamline clinical trial operations, including activation, recruitment, and regulatory workflows. She developed an accelerated start-up program that significantly reduced site activation and led to two nationwide COVID-19 convalescent plasma trials from site selection to publication in under 2 years. Lane has introduced innovations, such as automated site selection tools, site navigator tools, and gamified trial metrics to enhance performance. Her educational programs have supported over 200 NIH-funded sites. As a mentor for the Ann Dana Kusch Fellowship, she guides investigators in efficient trial methodologies. With over 50 publications, Lane has advanced electronic data systems, trial metrics and training platforms in clinical research.