Tracy Nolen, DrPH - Project Director and Principal Investigator
Dr. Tracy Nolen is a senior research statistician with more than 16 years of experience providing and managing analytic support for observational studies and clinical trials funded by commercial pharmaceutical and device companies, the Department of Defense (DoD), Department of Veteran Affairs (VA), and the National Institutes of Health (NIH). Dr. Nolen holds a Doctorate of Public Health degree in Biostatistics from the University of North Carolina at Chapel Hill’s Gillings School of Global Public Health and a master’s degree in Statistics from North Carolina State University. She specializes in the design, set-up, operation, analysis as well as scientific and regulatory reporting of clinical trials. Her statistical experience includes causal inference in observational and randomized trials settings; alternative study designs including adaptive dose finding designs and adaptive randomization algorithms; and the use of various statistical methods (e.g., regression analysis, including generalized linear models; longitudinal data analysis, including generalized estimating equation (GEE) and mixed models; survival analysis; nonparametric analysis; dose-proportionality analysis). She is a PASA Data Coordinating Center Project Director and Principal Investigator.
Nathan Vandergrift, PhD - Co-Principal Investigator
Nathan Vandergrift is a statistician with more than 15 years of experience in collaborative research in diverse areas such as public health–related infectious disease research, translational medicine from bench science, vaccine development, infectious disease treatment, community-level intervention for substance use disorder, pharmaceutical trials for substance use disorder, and large-scale educational and child development. His areas of statistical expertise are structural equation modeling, nonlinear and linear mixed-effects modeling, generalized linear models, nonparametric statistics, missing data, and statistical matching. Dr. Vandergrift has a depth of experience applying for, receiving, and executing large multisite UM1 and P01 grants and contracts and R01-level grants. He has led statistical teams and been a part of large collaborative research groups spanning many sites, countries, and continents. These collaborations have resulted in publications in highly regarded peer-reviewed journals. Dr. Vandergrift is the PASA Data Coordinating Center Co-Principal Investigator.
Meg Crawford – Clinical Research Manager
Meg Crawford is a research clinical studies specialist and manager in the Center for Clinical Research Network Coordination at RTI International. She has more than 15 years of experience managing clinical trials in multi-site networks, is certified as a clinical research professional, and is trained in good clinical practices. Ms. Crawford serves as the clinical research manager on the Pharmacotherapies for Alcohol and Substance Abuse Consortium (PASA). Her responsibilities include developing protocols, study manuals, and informed consent documents; developing or monitoring case report forms; reviewing adverse event experience reports; and ensuring protection of subjects and subjects’ rights through institutional review board relations. Ms. Crawford’s responsibilities also include budget development, report preparation, education and protocol training of other research professionals, project administration, and research project audits.