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Clinical Trials Site Advisory Council

Practical Site-Level Insight for Sponsors and CROs

The Clinical Trials Site Advisory Council brings together global academic researchers, community principal investigators, and experienced clinical coordinators who live the day-to-day realities of patient enrollment. Their collective expertise ensures that sponsors and CROs benefit from practical, data-driven feedback on protocol design, recruitment strategies, and site operations.

How Our Council Adds Value

By incorporating the perspectives of those on the ground, the Clinical Trials Site Advisory Council helps sponsors and CROs:

  • Anticipate and overcome enrollment barriers before they slow recruitment

  • Align expectations with real-world site capabilities

  • Refine study design and patient engagement strategies for better uptake

  • Strengthen collaboration between sites, sponsors, and CROs to ensure trials stay on track

The Council meets quarterly to review emerging lessons from across our 200-site network and issue recommendations that translate directly into improved trial performance. Their first white paper, focused on lessons learned from iQualifyCeliac, will provide sponsors with actionable insights on accelerating enrollment while reducing screen fails and site burden.

Meet the Clinical Trials Site Advisory Council

  • Dawn Adams, MD, MS, CNCS

    Vanderbilt University, USA

    President, SSCD




    Dr. Dawn W. Adams is an adult gastroenterologist with a special interest in small bowel enteropathies and nutritional complications of gastrointestinal diseases. She is an Associate Professor of Medicine in the Division of Gastroenterology, Hepatology and Nutrition, Department of Medicine, at Vanderbilt University Medical Center. Dr. Adams has a masters of science in nutrition and a specialization as a clinical nutrition support specialist (CNSC). She manages the inpatient and outpatient parenteral nutrition program for VUMC and longitudinally cares for patients with intestinal failure. In addition, she founded and directs the Vanderbilt Celiac Clinic which provides comprehensive care for patient with celiac disease including clinical research and social outreach.
    Dr. Adams is director of the Center for Human Nutrition which focuses on a multidisciplinary approach to patient care for the above mentioned diseases. Her excellent team consists of clinical providers, pharmacist, dietitians, nurses and program managers. She also serves as Medical Director for the VUMC collaborative home infusion program with Optioncare Health and is the President of the Society for the Study of Celiac Disease (SSCD).
  • Robert Anderson, MB ChB PhD

    Novoviah Pharmaceuticals, Australia

    President, ISSCD




    Dr. Bob Anderson is an Australia-based gastroenterologist, translational immunologist, and pharmaceutical and diagnostic developer. Dr Anderson has a global and multi-disciplinary perspective on celiac disease. He trained in medicine and completed a doctorate in New Zealand, and then completed specialist gastroenterology training in Melbourne, Australia. His research in celiac disease began as a post-doctoral fellow at Oxford University focused on T cells and continued in Melbourne and then Boston USA designing and overseeing preclinical and clinical development of gluten-specific immunotherapy. He has led basic, preclinical and clinical research and pharmaceutical development programs focused on defining and modifying the adaptive immune response to gluten. He is a clinician-scientist who has worked closely with celiac disease patient support groups and industry. Currently, he is leading commercial development of T-cell diagnostics at Novoviah Pharmaceuticals, advises biopharmaceutical developers, and practices clinical gastroenterology at Mackay Base Hospital. Dr. Anderson serves as the President of the International Society for the Study of Celiac Disease and as the Celiac Disease Foundation’s Principal Science & Innovation Advisor. He is a recipient of the global Prize for Excellence in Celiac Disease Research and the Maki Celiac Disease Tampere Prize for significant contribution to the fields of Celiac Diseases and Gluten-induced Disease Entities.

  • Julio C. Bai, MD

    Universidad del Salvador, Argentina

    Co-Chair, LASSCD




    Professor Julio C. Bai is an emeritus professor of medicine at the University del Salvador in Buenos Aires, Argentina, as well as a consultant at the Dr. C. Bonorino Udaondo Gastroenterology Hospital. He graduated from the University of Buenos Aires in 1970, at the age of 22. He was also a visiting assistant professor at the University of Texas, Dallas. His areas of interest are: celiac disease, non celiac gluten sensitivity, diagnostic and follow-up markers, video capsule endoscopy, inflammatory bowel disease, abnormalities with the intestinal barrier, intestinal microbiota, probiotics and new therapeutics for celiac disease. He began researching celiac disease during his first years of residency and has published over 400 papers in internationally recognized journals. Dr. Bai is the Co-Chair of the Latin American Society for the Study of Celiac Disease (LASSCD), a Committee of the International Society for the Study of Celiac Disease (ISSCD).

  • Adam Bledsoe, MD

    Mayo Clinic, USA

    Assistant Professor of Medicine




    Dr. Adam Bledsoe is an assistant professor of medicine and gastroenterologist at the Mayo Clinic in Rochester, Minnesota. He completed medical school at the University of South Dakota Sanford School of Medicine before internal medicine residency and GI fellowship at the Mayo Clinic. He provides clinical and endoscopic care to adult patients with disease of the gastrointestinal tract, with a special focus on celiac disease, immune-mediated gastroenteropathies, and endoscopic therapies. Complementing his clinical work, Dr. Bledsoe’s research interests include improving our understanding of celiac disease and related small bowel disorders. He has a special interest in clinical trials evaluating new therapies for these patients.

  • Carlo Catassi, MD

    Polytechnic University of Marche, Italy

    Past President, SIGENP




    Dr. Carlo Catassi is professor of pediatrics at the Polytechnic University of Marche, Ancona, Italy and adjunct faculty at the Massachusetts General Hospital, Harvard Medical School, Boston, USA. He is past president of the Italian Society for Pediatric Gastroenterology and Nutrition (SIGENP) and scientific consultant for the Instituto Superiore di Sanità in Rome, Italy, for the D1Ce pilot study on pediatric screening for celiac disease and type 1 diabetes. His primary research interests are celiac disease and other gluten related disorders, particularly the worldwide epidemiology, the clinical spectrum, pediatric screening and safe threshold of gluten intake. Dr. Catassi is a member of the International Society for the Study of Celiac Disease (ISSCD) Gluten Safety Standards Committee.

  • Z. Stella Sever Chroneos, PhD, CCRP

    Penn State Hershey Medical Center, USA

    Research Project Manager




    Dr. Zvjezdana Sever Chroneos is a Research Project Manager in the Division of Gastroenterology and Hepatology at Penn State Milton S. Hershey Medical Center, where she oversees industry-sponsored clinical trials focused on gastrointestinal and immune disorders, including celiac disease. She holds a PhD in Cell Biology from the University of Cincinnati, is certified as a Clinical Research Professional by the Society of Clinical Research Associates, and is pursuing a Master’s in Project Management at Penn State. With over two decades of experience in clinical and translational research, teaching, and volunteer leadership, Dr. Chroneos brings deep expertise and a strong commitment to advancing patient care and community engagement.

  • Kofi Clarke, MD, FACP, FRCP, AGAF

    Penn State Hershey Medical Center, USA

    Graham H. Jeffries Endowed Professor of Medicine




    Dr. Kofi Clarke is Professor of Medicine and Chief of the Division of Gastroenterology and Hepatology at Penn State Hershey College of Medicine, where he also serves as the Graham H. Jeffries Endowed Professor of Medicine. His clinical and research interests focus on inflammatory bowel disease, celiac disease, and graduate medical education, and he has served as site principal investigator for numerous multicenter clinical trials. Widely published in the field, Dr. Clarke is an active member of several leading professional societies and contributes as a reviewer and editorial board member for major gastroenterology and internal medicine journals.

  • Karen Dunn, MD, CPI

    North Carolina Clinical Research, USA

    Assistant Medical Director




    Dr. Karen Dunn is the assistant medical director at NCCR since 1988. She has served as a sub-investigator or principal investigator for over 650 studies. Dr. Dunn is a Certified Physician Investigator (CPI) and has helped pharmaceutical companies as a consultant and protocol review. As an investigator, Dr. Dunn is involved with all aspects of our clinical studies and particularly enjoys spending time with the patients. She is board certified in allergy/immunology and pediatrics.

  • Chadrick Hinson

    Mayo Clinic, USA

    Senior Research Coordinator




    Chadrick Hinson is a senior research coordinator at Mayo Clinic in Rochester, Minnesota, where he supports multiple clinical trials in celiac disease. He has served as a study contact and coordinator for interventional and observational research, including early-phase therapeutic trials and investigations of immune response in patients with celiac disease.

  • Brian Hollis, MD, CPI

    Quality Clinical Research, USA

    Medical Director




    Dr. Brian Hollis is the medical director at Quality Clinical Research (QCR). He has served as a principal investigator and sub-investigator for numerous clinical trials across a wide range of therapeutic areas. Dr. Hollis is a Certified Principal Investigator (CPI) and has contributed to the training of new clinical research professionals through national workshops. As an investigator, Dr. Hollis is involved with all aspects of clinical studies and values the opportunity to work closely with patients throughout the research process. He earned his medical degree from Creighton University School of Medicine, completed his residency in internal medicine at the VA Medical Center in Omaha, and is board certified in internal medicine.

  • Jennifer Larsen

    Quality Clinical Research, USA

    Clinical Research Coordinator




    Jennifer Larsen brings more than 28 years of experience in clinical research, with expertise spanning roles as Site Director, Clinical Research Coordinator, Regulatory Specialist, and Quality Control/Monitoring. She has served in supervisory positions for over two decades and has extensive experience guiding research operations. In addition, Jennifer is a previously licensed Radiologic Technologist with 30 years of practice and 25 years of specialization in Bone Densitometry. Jennifer received her Bachelor of Science Degrees in Leadership and in Healthcare Administration from Creighton University. Her background combines leadership in research with deep clinical and technical expertise, offering a unique perspective to advancing clinical studies.

  • Maureen Leonard, MD, MMSc

    MassGeneral Hospital for Children, USA

    President-Elect, SSCD




    Dr. Maureen Leonard is the Director of the Center for Celiac Research and Treatment at Massachusetts General Hospital for Children (MGHfC) and an Associate Professor at Harvard Medical School. She is a pediatric gastroenterologist specializing in celiac disease and gluten-related disorders, with a focus on research into celiac disease prediction and prevention, including the use of biomarkers and studies on environmental factors. Dr. Leonard also has a Master’s degree in Clinical and Translational Investigation and has received the Celiac Disease Foundation Young Investigator Prize. Dr. Leonard is the President-Elect of the Society for the Study of Celiac Disease.

  • Michael Schumann, MD

    Charité University Hospital, Germany

    President, ESSCD




    Michael Schumann is a medical doctor and gastroenterologist working at the Charité University Hospital in Berlin as an attending physician in the Department for Gastroenterology, Rheumatology and Infectious Diseases. He is doing research on the intestinal barrier in celiac disease and on treatment-refractory celiac disease (RCD) with a focus on evaluating molecular diagnostics for RCD.

  • Marisa Stahl, MD, MS

    Colorado Children's Hospital, USA

    Treasurer, SSCD




    Dr. Marisa Stahl is the Director of Research at the Colorado Center for Celiac Disease (Children’s Hospital Colorado) and an Assistant Professor at the University of Colorado School of Medicine. She is a pediatric gastroenterologist with a focus on celiac disease clinical care and celiac disease screening research in both high-risk groups and the general population. Dr. Stahl also has a Master’s degree in Clinical Science and has received the Celiac Disease Foundation Young Investigator Prize. Dr. Stahl is the Treasurer of the Society for the Study of Celiac Disease.

  • Fabiana Zingone, MD, MSc, PhD

    University of Padua, Italy

    Treasurer, ISSCD




    Dr. Zingone is an Associate Professor at the Gastroenterology Unit of the Azienda Ospedale–Università di Padova, University of Padua, Italy. Her clinical and research activities focus on immune-mediated gastrointestinal disorders, particularly celiac disease. She serves on the board of the Italian Society of Gastroenterology and Digestive Endoscopy (SIGE) and the International Society for the Study of Celiac Disease (ISSCD), where she chairs the Directions Committee dedicated to the study of non-responsive celiac disease. She also holds a Master’s degree in Applied Epidemiology and has recently received the UEG Rising Star Award 2025.

Built-In Advantage for Sponsors and CROs

When you partner with iRecruitCeliac, you don’t just access the industry’s most powerful patient recruitment platform—you also gain the collective insight of our Clinical Trials Site Advisory Council. This council’s real-world site perspectives are fully integrated into your experience, ensuring that every study benefits from practical, data-driven guidance on design, recruitment, and site operations.