SOCRA Quality Management Virtual Conference

Includes Multiple Live Events. The next is on 08/13/2026 at 12:30 PM (EDT)

Goal: To equip clinical research professionals with the knowledge, skills, and practical tools needed to develop, implement, and sustain effective quality management practices that promote regulatory compliance, inspection readiness, and continuous quality improvement in clinical research.

Objective:  This workshop provides participants with current regulatory updates, best practices, and real-world applications related to quality management systems, FDA inspections, Good Clinical Practice (ICH E6(R3)), self-monitoring, audit readiness, root cause analysis, CAPA development, and emerging trends impacting quality management. Through expert-led presentations and interactive discussions, attendees will strengthen their ability to build and maintain robust quality programs across a variety of clinical research settings. Please contact us with any questions or concerns at education@socra.org.

Learning Objectives: Upon completion of the workshop, the attendee should be able to:

  •  Explain the core principles of quality management systems and their application within clinical research in accordance with FDA regulations and ICH E6(R3) Good Clinical Practice guidelines.
  •  Describe recent changes in FDA regulatory oversight and evaluate their impact on quality management, inspection preparedness, and data integrity.
  •  Apply quality management tools and self-monitoring strategies to identify risks, strengthen oversight, and improve research operations.
  •  Recognize common causes of systemic non-compliance and implement appropriate corrective and preventive action (CAPA) strategies using root cause analysis.
  •  Develop effective audit and inspection readiness plans, including preparation, response, and follow-up activities.
  •  Interpret quality assurance and quality control trends to identify training needs and support continuous quality improvement initiatives.
  •  Assess the impact of emerging technologies and evolving practices—including artificial intelligence (AI), decentralized clinical trials (DCTs), and other innovations—on quality management programs.

Please contact us with any questions or concerns at education@socra.org.

Nancy Wintering, MSW, LCSW, CCRP

Nancy Wintering, MSW, LCSW, CCRP (Moderator)

Assistant Director of Research

Marcus Institute of Integrative Health at the Thomas Jefferson University

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, BS, MS, CCRP

Janelle Allen, BS, MS, CCRP (Moderator)

Professional Consultant, Corporate trainer, and Faculty Member

Miami University

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, MPH, CCRP

Alyssa Gateman, MPH, CCRP (Moderator)

Executive Director, Yale Cancer Center Clinical Trials Office

Yale Cancer Center Clinical Trials Office

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. 

Components visible upon registration.