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.
Amy Kendrick RN, MSN – Clinical Research Manager
Amy Kendrick 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 hospital/ICU based experience, followed by 20 years of experience managing clinical trials in multi-site networks. After receiving her master’s degree in nursing, Ms. Kendrick got an additional degree in Clinical Research Management. Ms. Kendrick serves as the lead clinical research manager on the Pharmacotherapies for Alcohol and Substance Use Disorders Alliance (PASA). Her responsibilities include overseeing all aspects of clinical research projects. Ms. Kendrick is experienced in the creation of study documents, which includes, but is not limited to: guidance documents and manuals of operations, standard operating procedures, protocols, consent forms, study tools, and case report forms. Ms. Kendrick has experience as well in clinical research monitoring and pharmacovigilance reporting and processing. Ms. Kendrick’s responsibilities also include monitoring budgets and finance, sponsor reporting activities, facilitating staffing and training of PASA team members, and general coordination of activities across team members' areas of expertise (eg: biostatistics, information technology, data management, study management, finance, and contracts).