Nancy Wintering is the Assistant Director of Research at Thomas Jefferson University’s Marcus Institute of Integrative Health and a recipient of the 2022 SOCRA President’s Special Recognition Award. A Licensed Clinical Social Worker with over 30 years of experience, she has overseen Phase I–III research studies and is a strong advocate for patient-centered research and community collaboration.

A Certified Clinical Research Professional (CCRP) since 2007, Nancy has held multiple leadership roles within SOCRA and served as faculty across several training programs. She is a prolific educator and author, having coauthored over 75 peer-reviewed articles and numerous book chapters, and has mentored nearly 100 student interns. Nancy is dedicated to advancing the clinical research profession through education, mentorship, and improved communication in the informed consent process.

Janelle Allen is a professional consultant, corporate trainer, and faculty member in the Department of Biology at Miami University and teaches clinical research graduate courses and is a professional mentor at the College of Medicine for the University of Cincinnati Graduate College. Prior to which, she served as the Director of Clinical Research Operations, Quality, and Education at the Institute for Advanced Clinical Trials for Children (I-ACT for Children) for a pivotal USA FDA national/international pediatric initiative. Before her time at I-ACT, she spent a decade at Cincinnati Children's Hospital Medical Center serving as a Project Manager and Clinical Research Coordinator within the Pain Research Center & Headache Center, managing multiple NIH, foundation, and centrally sponsored trials in the Pediatric Neuroimaging Research Consortium. Over the past 29 years, she has completed extensive research on state-based care centers and services, developmental biology, neurophysiology and neurobehavior, quality engineering: analytical and quality product review, molecular cardiovascular medicine, infectious diseases, child behavior and nutrition, headache / migraine, pain, and network-based initiatives within multiple site, industry-based, national and international clinical trials, as well as the scholarship of learning. Allen currently serves as the chair of the Southwestern Ohio SOCRA Chapter, and as the executive director of the Greater Cincinnati Association for Women in Science (GCAWIS). In the past, she has served on the SOCRA Board of Directors, as the Chair of the Leadership Council of Clinical Research Professionals, and has held several positions based on Education, Certification, Mentorship, Networking / Collaboration, Membership, and Special Projects. She assisted Cincinnati Children's Hospital Medical Center in developing educational and training materials, professional courses, certification curriculum, a robust professional mentorship program, and manuals for clinical research professionals (CRPs) in the areas of clinical research skills; clinical research project management, data management, and recruitment/retention; electronic Protocol Administration System (ePAS); Research Electronic Data Capture (RedCap); Electronic Medical Record (EPIC Systems), and home and on-site safety in clinical research. She served on the 2014 Office for Human Research Protections (OHRP) Research Community Forum Planning Committee. She also works in community development and youth/young adult development as the executive director of Cincinnati Young Professionals (Cincy YP), enjoys working with CRPs & research teams, and helping families lead happier, healthier lives. In 2022, she was awarded the Cincinnati Top Ten Award from the State of Ohio for her leadership, advocacy, and mentorship. Allen received a Bachelor of Science from Miami University in Biology, Neuroscience, Chemistry, and French and a Master of Science from Miami University in Biology: Physiology and Neuroscience. She also maintains her professional clinical research certification and advocates for CRP Certification (CCRP).

Alyssa Gateman currently serves as the Executive Director of the Yale Cancer Center Clinical Trials Office. Since joining Yale in July 2014, she has also held the role of Senior Associate Director of Quality Assurance and Research Regulatory Initiatives at the Yale Center for Clinical Investigation. Prior to her time at Yale, Ms. Gateman was Director of the Quality Assurance Office for Clinical Trials at Dana-Farber/Harvard Cancer Center. 

Ms. Gateman is deeply committed to advancing the clinical research workforce through education and mentorship. In addition to her long-standing involvement with SOCRA, she serves as Adjunct Faculty at Southern Connecticut State University, where she teaches Good Clinical Practices and Clinical Trial Administration as part of the Healthcare Studies undergraduate program. A dedicated SOCRA member, she will celebrate 22 years of membership and 19 years of certification in 2025. She is a former SOCRA Board member, frequent presenter for SOCRA and currently serves as the inaugural President of the Connecticut SOCRA Chapter. 

Outside of work, Ms. Gateman enjoys supporting the Yale Junior Bulldogs hockey team as a coach’s wife and goalie mom, and spending time with her golden retriever, Biscuit. 

Lisa Winkowski serves as the Manager-Regulatory & Compliance for the Mayo Clinic Comprehensive Cancer Center (MCCCC), where she leads a team that supports enterprise-wide Sponsor-Investigator research activities. The MCCCC Compliance Team partners closely with Data Safety Monitoring Committees and Boards and provides oversight and support for FDA regulatory management, ClinicalTrials.gov and CTRP registration and maintenance, data management, external site oversight, monitoring, auditing, and study team consultation throughout the clinical research lifecycle.
Lisa earned her Bachelor of Science degree from Iowa State University and obtained the Certified Clinical Research Associate (CCRA) credential in 2007. She began her clinical research career in 2006 with NewLink Genetics, supporting early-phase oncology clinical trials and gaining experience in clinical operations, regulatory affairs, and safety oversight activities.
In 2011, Lisa joined Quintiles (now IQVIA) as a Senior and Lead Clinical Research Associate, where she supported multicenter clinical trials across several therapeutic areas, including oncology, cardiology, dermatology, and nephrology. During this time, she contributed to the successful execution of complex clinical studies and mentored fellow clinical research professionals.
Lisa joined the Mayo Clinic Comprehensive Cancer Center in 2017 as a Compliance Manager. In this role, she has partnered with Data Safety Monitoring leadership and enterprise stakeholders to advance research quality, compliance, and operational excellence across the clinical research enterprise. Her work has included transforming the MCCCC investigator-initiated trial (IIT) audit program, developing corrective and preventive action (CAPA) processes, establishing monitoring and external site management programs for multi-site IITs, and implementing process improvements that strengthen oversight of Sponsor-Investigator research activities.
With over 17 years of experience spanning sponsor, contract research organization (CRO), and academic medical center environments, Lisa brings extensive expertise in clinical trial oversight, regulatory compliance, quality management systems, monitoring, auditing, and Sponsor-Investigator research operations.

Abby Statler is currently the Senior Director of Clinical Quality Assurance at AVEO Pharmaceuticals, Inc. In her current position Abby is responsible for Quality oversight of Clinical Operations, Clinical Development, and Pharmacovigilance at AVEO. She leads strategic and operational management of the Clinical Quality group and collaborates across cross functional departments, overseeing the appropriate processes, systems, and activities to secure compliance with US (FDA) and International (ICH) regulations and Guidance. Previously, as the Director of Research Quality and Safety at Dartmouth Health Abby oversaw clinical research quality and compliance activities across the Dartmouth Health System, partnering with the Office of Research Operations leadership to develop and execute the institution’s GCP/GVP quality management strategy. Prior to joining the Office of Research Operations at DH Abby spent 10+ years developing, implementing and maintaining the Cleveland Clinic Cancer Institute’s Quality Assurance Department. She also has her PhD in Population and Quantitative Health Sciences; her dissertation focused on providing empirical evidence to support the modernization of eligibility criteria for hematologic malignancy clinical trials. 

Dr. Craig A. Garmendia is Director of Quality Science & Strategy at AstraZeneca, where he leads initiatives at the intersection of clinical quality, emerging technologies, and innovation in clinical trials, including the application of artificial intelligence.

Prior to joining AstraZeneca’s Barcelona Global Hub, Dr. Garmendia served with the U.S. Food and Drug Administration (FDA) as a Foreign Expert (Investigator) and Foreign Cadre Director within the Bioresearch Monitoring Program. As a member of the inaugural cohort of dedicated foreign investigators, he conducted international inspections and data audits to evaluate the conduct, integrity, and reporting of FDA-regulated clinical research across countries worldwide.

Dr. Garmendia earned a Bachelor of Science in Chemistry from Florida International University (FIU), a Master of Science in Chemistry from Vanderbilt University, and a Doctor of Philosophy in Public Health, with a specialization in Epidemiology, from the Robert Stempel College of Public Health & Social Work at FIU.

His contributions to public health and clinical research have been recognized with the FDA Office of the Commissioner Honor Award, and his work has been published in JAMA Internal Medicine and other leading medical and bioethics journals.

Anne E. Johnson is an independent consultant and senior regulatory executive with over 35 years of U.S. Food and Drug Administration (FDA) experience in conducting and overseeing inspectional, compliance, and regulatory operations. She holds expertise in regulatory strategy, inspection techniques, and enforcement across all commodity areas. As a proven leader in clinical research and medical product operations, strategic policy development, incident response, complex fiscal management, and operational transformation, she is a trusted advisor on regulatory matters, compliance risks, and nationwide programs. She possesses advanced skills in capital investiture, resource planning, and financial acumen. Ms. Johnson is recognized for driving performance, advancing organizational effectiveness, and building workforce capabilities across complex, multi-disciplinary regulatory environments, with a global footprint.

As Senior Science Advisor to the Associate Commissioner, Office of Regulatory Affairs and Office of Inspections and Investigations at the FDA, she was principal advisor and strategic partner on regulatory policy, domestic and international inspectional, import, and laboratory operations, nationwide field strategies, policies, workforce analyses and execution of public health initiatives for 5000+ employees. As the Director, Office of Bioresearch Monitoring Operations, East Division, Ms. Johnson built and established the BIMO program, East Division, directing inspectional operations with oversight for GCP, GLP, pharmacovigilance and REMS inspection and investigative activities across the eastern third of the U.S., Puerto Rico, and USVI. She led agency modernization and harmonization efforts of BIMO inspectional strategies and compliance programs, training, creating and modernizing policies and procedures. She also conceptualized, and implemented the national SOP for multi-commodity inspections, integrating compliance outcomes with cross-programmatic coverage. Ms. Johnson pioneered and delivered strategic clinical research training programs in partnership with leading academic institutions and international industry associations.
Her professional network includes the Society of Clinical Research Associates and the FDA Alumni Association. She is active on the speaking circuit. Ms. Johnson is the principal consultant of Aventra Advisors, LLC, a regulatory consulting firm specializing in inspectional preparedness and compliance operations, providing compliance risk and strategic advisory services internationally, within the life sciences sector.