Fundamentals of Research Coordination

Organization: Johns Hopkins Bloomberg School of Public Health – Johns Hopkins Biostatistics Center

My primary expertise is in data management practice and implementation for public health research. I collaborate with public health researchers to help them design and implement good data management systems and procedures to manage their data through the entire research lifecycle. For the more than 27 years, I have been involved with public research at the Johns Hopkins Bloomberg School of Public Health both in the United States and abroad. During my first 11 years, I worked in the Department of International Health supporting large, maternal mortality trials in Nepal and Bangladesh as well as anemia prevention trials in East Africa. For the past 16 years, I have been the director of data management services in the Johns Hopkins Biostatistics Center (JHBC) at the Johns Hopkins Bloomberg School of Public Health. The JHBC serves researchers across all the schools at Johns Hopkins University, and I manage a team of data consultants and programmers that provide data management expertise to researchers at all stages of their research. In addition to my role as a director of data management services in JHBC, I am also a faculty member in the Department of Biostatistics, and I teach a course on data management during 3 academic terms and the Summer Institute each year. I also give lectures on data management practice for various groups as a component of their broader training for researchers and study team members. In my practice, I’m constantly pushing myself and my team to keep our skillsets current so that we can use the state-of-the-art tools with our collaborators. I strive to translate my hands-on experiences in supporting researchers and integrate what I’ve learned back into the training I do in my data management courses. This gives my students current, relevant knowledge and skills that they can immediately use as they embark on their own research and manage their data.

Organization: Division of General Internal Medicine at Johns Hopkins
Faculty Member of the Johns Hopkins Berman Institute of Bioethics

Mark Hughes is a clinician-educator in the Division of General Internal Medicine at Johns Hopkins and a core faculty member of the Johns Hopkins Berman Institute of Bioethics. He co-chairs the Johns Hopkins Hospital Ethics Committee. His work in research ethics has included serving as a guest observer on the IRB of the National Heart, Lung, and Blood Institute (NHLBI), serving as the ethics consultant on two different Data Safety and Monitoring Boards at the NHLBI, serving as an alternate member on the JHM IRB, and coordinating educational experiences for IRB members and investigators in the Schools of Public Health, Nursing, and Medicine. In addition to lecturing for the RCTP, Dr. Hughes directs the course REWards, Research Ethics Workshops about responsibilities and duties of scientists, aimed at investigators performing human subjects research in the School of Medicine. He is also co-developer and director of the course, Introduction to Responsible Conduct of Research, for graduate students in the School of Medicine.

Organization: Milestone Regulatory Experts, LLC

After beginning his biomedical research career in the mid-90’s as a SAS statistical programmer and clinical data analyst, Che later broadened his quantitative foundation by obtaining an international relations graduate degree in the mid oughts; this fostered a greater understanding of the industry’s regulatory and compliance-related dimensions. After two decades of experience working for pharmaceutical firms, contract research organizations, and academic research centers, Che launched Milestone Regulatory Experts, LLC in 2017 to provide cost-efficient and exemplary service to clients seeking assistance with regulatory affairs, Health Authority eCTD regulatory submissions, GCP auditing/monitoring/compliance, project management, training/curriculum development, or professional speaking services.

Organization: Institute for Clinical and Translational Research at the Johns Hopkins School of Medicine

Cassie is the Assistant Director of the Recruitment Innovation Unit (RIU) within the Institute for Clinical and Translational Research at Johns Hopkins School of Medicine. She has over 28 years of professional experience in clinical trial recruitment and retention, with extensive expertise in recruiting adult, pediatric, and underserved populations (i.e., minority and rural) into clinical trials. Her current work involves managing an office that studies the science of recruitment of diverse populations in studies, with an emphasis on using digital technologies to engage potential participants.

Organization: Johns Hopkins University
School of Medicine
Office of Human Subjects Research

For my primary position, I direct the Johns Hopkins University’s Office of Human Subjects Research (the IRB) Compliance Monitoring Program, for which I utilize my experience in clinical research and training in regulatory compliance. In particular, I over-see remote routine and priority monitoring and for-cause/directed audits of JHU human subjects research protocols. Inthis role I apply my knowledge of Federal regulations, Institutional requirements, and GCP Guidelines, to assess compliance at all applicable levels. Further, I consult with investigators to identify deficiencies in regulatory compliance and a protocol’s procedural conduct, in addition to generating corrective action and quality management and improvement mechanisms to maximize attention to a culture of quality and safety whereby the rights, well-being, and safety of research subjects are safeguarded. Finally, I develop and present educational and training sessions for the JHU research community regarding Human Subjects Research compliance and best-practices. These programs are offered at the JHU Schools of Medicine, Public Health, and Nursing.

For my second position, my effort is supported by the JHU Institute for Clinical and Translational Research (ICTR), a CTSA funded center. My position is the Research Participant Advocate for theJohns Hopkins Bayview Medical Center Clinical Research Unit (B-CRU). My responsibility is to serve as an objective resource or ombudsman for all research participants, and also for the community at large, from which many of our studies draw participants. Second, I function as a regulatory resource for the JHU researchers and B-CRU research staff. In addition, I review protocols for attention to human subject safety in both their design and conduct, focusing on the quality and adequacy of a given study’s Data Safety Monitoring Plans. To this end, I also serve in an educational and consultative capacity to assist the client investigators and study-teams utilizing our Unit. Within this role, I have also developed and currently direct the JHU ICTR’s Data Safety Monitoring Service, whereby I assist and guide investigators across the JHU community with the development of Data Safety Monitoring Plans and with the assembly of Data Safety Monitoring Boards (DSMBs), along with writing DSMB Charters, if necessary.

Organization: Institute for Clinical and Translational Research
Johns Hopkins University School of Medicine

Ms. Martinez is the Research Participant Advocate for the Johns Hopkins (JHU) Institute for

Clinical and Translational Research (ICTR). In this position, Ms. Martinez provides support to Research Participants and Research Staff to encourage safe and ethical conduct of Clinical Research.

Ms. Martinez has over 38 years of clinical research experience at Johns Hopkins University and has been a Certified Clinical Research Coordinator since 1998.

Organization: Research Management Services (RMS)
School of Medicine (SOM)
Johns Hopkins University

I’m a trained Sr. Grants & Contracts Analyst providing financial management support that includes grant funding for research and clinical trials in the SOM Research Management Services (RMS) department.  I’ve been managing departmental budgets since 1996 with a focus on awarded grant funding.  After managing pre- and post -award grant activities for five years in the Institute for Clinical and Translational Research (ICTR), I moved to RMS to focus more on the management of clinical trials research funding.  

I started my research administration career in JHU’s Research Administration office as a Limited Submissions Specialist in 2010.  I had a great opportunity to co-present a session on Limited Submission at the NCURA Regional 5 Conference in 2015 and I’ve been presenting on Budgets and Finance for the SON FRC Program since 2019.

Organization: Bloomberg School of Public Health

Tariq Syed, Pharm D has worked as a Sr. Research Analyst (Jan. 2010-Present), and Assistant Director for Institutional Coordination (Oct. 2018-Present) at the Bloomberg school of Public Health (BSPH) Institutional Review Board (IRB). He has taught the IRB section of the RCTP course since 2013. Dr. Syed has extensive experience and working knowledge of both regulatory requirements and various pharmaceutical dosage forms. Prior to joining the BSPH IRB Dr. Syed served as a scientist for a drug company (Pharmaceutics Int. Inc.) for a period of 3 years. During this time, he also held different positions in both retail and hospital pharmacies. Dr. Syed earned his B.S. in Pharmacy from Karachi University in Pakistan in 2003, his M.S. in Clinical Research Administration from The George Washington University in 2009 and Pharm D. degree from Karachi University in Pakistan in 2012. He has been an active registered Pharmacist and Immunizer in the State of Maryland since May 2014.

Organization: American Urological Association

Stephanie’s career in research spans 24 years, demonstrating her adaptability and commitment to the field. Her journey began with undergraduate studies and research in Chemical Engineering, but she soon found her passion in research related to people, behaviors, (and, eventually, health).  This led her to earn a double major BA in Psychology and Sociology in 2004, followed by a Master’s in Applied Sociology in 2008 at the University of Maryland Baltimore County.

While in graduate school, Stephanie started her career at Johns Hopkins in 2005.  Initially not interested in health research, she took a job as a Research Data Coordinator II for the Pediatric Asthma and Allergy department to help pay school bills.  During this position, through exposure and interaction with other research staff, Stephanie’s love for clinical research, particularly the role of the Clinical Research Coordinator, was ignited.

Stephanie became a Research Coordinator in 2006 with the Johns Hopkins Adult Epilepsy Department and was eventually promoted to Senior Research Coordinator. While working in Epilepsy, Stephanie noticed a need for further education and training of research staff and the standardization of clinical research processes, not only within Neurology but institutionally at Johns Hopkins.

Stephanie’s influence extended beyond her role in the Adult Epilepsy Department.  She became a driving force in departmental and institutional-level policy change initiatives, a role she continued when she joined the Institute for Clinical and Translational Research (ICTR) in 2010, showcasing her influence and leadership.

During her time at the ICTR, Stephanie’s career was diverse and dynamic. She held many titles; she started at the ICTR as the Research Manager of the Office of Recruitment and Retention. She then developed and was the Director of the Study Coordinator Apprenticeship and Mentoring Program (SCAMP), and the Research Coordinator Support Service (RCSS).  In 2021 SCAMP was renamed the Coordinator Apprenticeship Program (CAP).

When the pandemic hit, Johns Hopkins leadership asked her to become a Research Administrator for the COVID Research Center, overseeing Inpatient COVID research at the Johns Hopkins Institutes. After the pandemic ended, Stephanie rounded out her 19-year career at Johns Hopkins as the Research Administrator for the Education and Training of Clinical Research Professionals.

Throughout her career at Johns Hopkins, Stephanie held many leadership roles, serving on many committees whose mission was to improve the education and training, and provide competency-based career paths for Clinical Research Professionals. She has also taught multiple Clinical Research Workshops internationally, at Sun Yet-Sen University in Guangzhou, China, and most recently at Johns Hopkins Aramco Health in Saudi Arabia in 2023.

Stephanie’s commitment to education and training is unwavering. In 2024 she left Johns Hopkins to become the Research Education Manager for the American Urological Association (AUA).  She is utilizing all her experience from her years at Johns Hopkins to help continue the wonderful education and training programs AUA already offers and work with her staff to expand the education and training, specifically surrounding clinical research, that AUA provides.