Overview
Johns Hopkins, an international leader in clinical research, is pleased to offer a brand-new course that takes professionals deeper into advanced topics.
Join us for this dynamic, two-day course hosted by the Johns Hopkins Institute for Clinical and Translational Research (ICTR), designed for clinical research professionals seeking to deepen their understanding of ethical research conduct and advanced task management. This hands-on training will cover advanced topics including, contracting, budgeting, REDCap, inspections and more.
Learn from experienced leaders in clinical research and gain practical tools to enhance your daily workflow. Don’t miss this opportunity to strengthen your impact in the research community!
Topics and Speakers
| Dr. Daniel Ford | Advanced Case Studies |
| Megan Singleton | Advanced IRB Topics |
| Janelle Maddox-Regis | Advanced IRB Topics |
| Liz Martinez | Advanced Topics of Informed Consent; Informed Consent Mastery |
| Maggie Leathers | Corrective Actions, Preventative Actions, CAPA |
| Stephen Capello | Creating Amazing SOPs, SOP Group Work |
| Alan Regenberg | Hard Cases in Research Ethics |
| Suzanna Roettger | Inspections and Audits |
| Kim Mudd | Learn from a High-Functioning Research Team |
| Dr. Christopher Chute | Making Sense of Big Data |
| Mais Hamdawi | Onboarding and Mentoring Research Professional, Advanced Case Studies |
| Cassie Lewis-Land | Recruitment and Retention |
| Cyd Lacanienta | Community Engagement |
| Scott Carey | REDCap |
| Karen Roz | Research Budgeting and Financial Management |
| Anthony Keyes | Source Documents that Work, Creating Amazing SOPs, SOP Group Work |
| Tom Burns | Working with Grants and Contracts |
Presenters
Scott Carey has worked in the clinical research informatics field since 1993, initially working with trauma/EMS registry software. After spending 5-years as the systems manager for the Maryland Cancer Registry, he worked closely with the AHA on a project to build and manage the National Registry of CPR (in-hospital resuscitation). Scott has been supporting Johns Hopkins clinical research since 2007, when he was hired to support the JH Bayview GCRC (General Clinical Research Center). That position was eventually rolled into the ICTR Informatics Core where Scott has been supporting clinical research throughout the JH community. Since bringing REDCap to the School of Medicine in 2010, Scott has worked to extend the reach or REDCap to research communities within Johns Hopkins and the integration of REDCap with systems such as EPIC. Scott is also recognized as a leader within the larger national/international REDCap community, speaking regularly at national and international events.
Dr. Daniel Ford is the David M. Levine Professor in the Department of Medicine, Division of General Internal Medicine, Welch Center for Prevention, Epidemiology and Clinical Research. He holds joint appointments in the Departments of Psychiatry, Epidemiology, and Health Policy and Management in the Johns Hopkins University Bloomberg School of Public Health and in the Johns Hopkins School of Nursing.
In 2005, he was appointed as Vice Dean for Clinical Investigation for the Johns Hopkins School of Medicine. In 2007, he became the first Director of the Johns Hopkins Institute for Clinical and Translational Research (ICTR). Dr Ford stepped down as Vice Dean in 2021 to concentrate on management of the ICTR. The ICTR is the home for clinical research informatics and community engagement programs for Johns Hopkins Medicine. His leadership decisions have demonstrated a strong commitment to building partnerships between research organizations and the community. Johns Hopkins is one of the centers in the NIH funded Clinical Trial Innovation Network working to improve the efficiency and quality of multicenter clinical trials. His research relates to co-management of physical and mental conditions and the prevention of cardiovascular disease.
Anthony Keyes is the Assistant Director of Clinical Workforce Operations at Johns Hopkins University, Institute for Clinical and Translational Research where he is responsible for several ongoing School of Medicine-wide projects. He has also served as a Study Coordinator and Research Manager and has 20 years’ experience in many aspects of clinical trial coordination and management.
Tony is a certified Project Management Professional and has successfully completed several, large-scale projects. He founded and directs the Johns Hopkins ClinicalTrials.gov Program and co-chairs the National Clinical Trial Registration and Results Reporting Taskforce. He also directs the Research Coordinator Support Service Program leading many early stage and mature research professionals to fill vital needs throughout at the University. Tony serves as the co-chair of the Clinical Research Professionals Taskforce and directs a research coordinator apprentice program to grow the next generation of qualified staff.
He received his MBA in Healthcare Management from the Johns Hopkins University, Carey Business School and a Bachelors of Biology from the University of Maryland, College Park.
Frederick Luthardt is the Director of the Johns Hopkins University’s Office of Human Subjects Research (the IRB) Compliance Monitoring Program (CMP), utilizing 27 years of experience in clinical research and knowledge of regulatory compliance and quality oversight. Fred has extensive expertise in Federal Regulations to assist investigators with the design, conduct, and oversight of FDA IND and IDE clinical trials. Fred develops and presents educational and training sessions for the JHU research community regarding Human Subjects Research compliance and best-practices, with many courses offered at the JHU Schools of Medicine, Public Health, and Nursing. Fred is also doctoral trained bioethicist, focusing on research ethics and organizational ethics.
Kim Mudd is the Nurse Manager of the Johns Hopkins Division of Pediatric Allergy, Immunology and Rheumatology Food Allergy Research Team and the Lead Coordinator for the Consortium of Food Allergy Research Leadership Center.
Kim has over 35 years of experience in food allergy research, education and community advocacy. She has received awards for her work in the area of food allergy including the American Academy of Allergy, Asthma and Immunology’s Allied Health Professionals Recognition Award. Kim has authored multiple publications and is the Lead Author of the AAAAI Oral Food Challenge Series.
Suzanna Roettger is the Associate Director of the Compliance Monitoring Program (CMP) in the Office of Human Subjects Research at Johns Hopkins School of Medicine. Suzanna has been with the CMP for 11 years, initially as a Sr. Compliance Monitoring Specialist for 5 years then transitioning to the Associate Director position. Suzanna began her research career 20 years ago as a study coordinator. Her experiences as study coordinator are where she developed her passion for ethical research grounded in ensuring the humanity of the research staff and participants while maintaining compliance with applicable policies and regulations.
Dr. Christopher Chute received his undergraduate and medical training at Brown University, internal medicine residency at Dartmouth, and doctoral training in Epidemiology at Harvard. He is Board Certified in Internal Medicine and Clinical Informatics, an elected member of the National Academy of Medicine, and a Fellow of the American College of Physicians, the American College of Epidemiology, and Distinguished Fellow of the American College of Medical Informatics. His career has focused on how we can represent clinical information to support analyses and inferencing, including comparative effectiveness analyses, decision support, best evidence discovery, and translational research. He has had a deep interest in semantic consistency, harmonized information models, and ontology. His current research focuses using real world clinical data for biomedical discovery, and how we classify dysfunctional phenotypes (disease). He has been PI on a large portfolio of research and has been active on many health information technology standards efforts and chaired the World Health Organization (WHO) ICD-11 Revision.
Mais Hamdawi is a dedicated Medical Doctor (M.B.Ch.B, Baghdad University) and clinical research professional at Johns Hopkins since 2020. She has contributed to 47 research studies across departments, building deep expertise in research coordination, leadership, and program management. Mais created and leads the Research Personnel Onboarding Program, which has delivered over 6,000 hours of training since 2022. She also manages the Research Coordinator Support Service and the Coordinator Apprenticeship Program. Her work ensures regulatory compliance, accelerates onboarding, and supports research teams institution-wide. Passionate about impactful research, Mais excels at solving complex challenges and advancing the quality and efficiency of clinical studies.
Maggie Leathers is a Senior Compliance Monitoring Specialist and the single IRB (sIRB) Monitoring Lead for the Compliance Monitoring Program within the Office of Human Subject Research. Maggie began her career as a Behavioral Therapist before transitioning to Research in 2013. She started as a Research Assistant at JHSPH and has since advanced to her current role at the School of Medicine. In her current role, Maggie Monitors both Priority and Routine studies, supports targeted audits, and evaluates Continuing Reviews for the sIRB/IRB Reliance Program. Maggie is committed to upholding the highest standards of ethics and compliance in research across the SOM, and serving as a resource to the research community.
Liz Martinez is the Senior Clinical Research Nurse Liaison and Research Participant Advocate for the Johns Hopkins (JHU) Institute for Clinical and Translational Research (ICTR). In this position that she has held for 18 years, Ms. Martinez works with Institutional Review Boards (IRBs), institutional clinical regulators, faculty investigators, research teams and ICTR personnel to facilitate overall compliance with human subjects safety regulations, and to generally foster within both the ICTR and the wider medical institutions an environment that promotes the safety of human research subjects, the compliance of research with clinical standards and the enhancement of the research participant experience. Liz has 39 years of clinical research experience at Johns Hopkins University and has been a Certified Clinical Research Coordinator since 1998.
Alan Regenberg, MBE is a faculty member and the Director of Outreach and Research Support at the Johns Hopkins Berman Institute of Bioethics. His work focuses on emerging biotechnologies, public engagement, the allocation of scarce resources, and research ethics. Alan is a member of an Institutional Review Board, and the Institutional Stem Cell Research Oversight Committee. He is the coordinator and a consultant for the Research Ethics Consultation Service. In addition to his own research portfolio, he and his team provide rapid-response support to Berman Institute researchers. They are also responsible for social media dissemination and active public engagement around the Institute’s work.
Karen Roz is the Senior Director for Clinical Research Support Services and Billing and is responsible for all prospective reimbursement analysis, budgeting and budget negotiations for all JHM clinical research, and for pre and post award financial management for all community based clinical research for the SOM faculty and all JHHS clinical staff performing clinical research.