In many settings, the detailed work of implementing a research study is delegated to the research coordinator or research nurse. Research staff are often responsible for managing grants and budgets, preparing regulatory submissions, writing study protocols, creating data collection forms, managing databases, developing recruiting plans, and supervising others. Individuals in this role know all too well the difficulties of learning on-the job.
Formal preparation is offered onsite and online to provide coordinators with the skills necessary to be successful in this very important role, including:
- Orientation to the professional role
- Training on all the components required in conducting of successful research
- Ongoing updates to Federal regulations and guidelines
- Expert mentoring from program faculty
- Basic and advanced programs to meet learning needs of both new and experienced coordinators
New--Online Orientation Modules
New to your role? Register for our Online Orientation for Research Staff. These self-paced learning modules are included when you register for the three-day fundamentals course.
Individual Module Pricing
Not interested in the three-day fundamentals course, but want access to the online modules? You can register for individual modules for $270, which are available 24/7.
About the Three Day Fundamentals Course
Designed for research nurses and research coordinators, the three day course trains you on all of the components required to manage a research study or program. The course is for members of the Johns Hopkins community and external audiences alike.
Prior to the three day course, each Fundamentals course participant completes the online, self-paced "Orientation for Professional Staff" at no additional charge. The 9 interactive orientation modules provide the baseline and common terminology for all course participants and is to be completed prior to the onsite course.
During the three day onsite experience, lectures and case studies are used to encourage discussion and each session is guided by Johns Hopkins subject matter experts.
Topics include how to:
- Responsibly conduct research
- Define and identify health disparities
- Manage grants and budgets
- Prepare regulatory submissions
- Write study protocols to comply with IRB regulations
- Create data collection forms
- Collect and manage data
- Develop recruiting and retention plans
- Supervise staff
What You'll Learn in Fundamentals
The overall goals of the course are to:
- Identify core knowledge and skills research coordinators should have to manage the daily activities of a research study and to conduct a study that is compliant with the protocol, Federal regulations and institutional policies;
- Provide ethical, regulatory and procedural information research coordinators need to safeguard the safety, well-being and rights of research subjects;
- Reinforce procedures and responsibilities research coordinators have to ensure integrity and quality of the research and the data collected.
- Ethical Considerations in Human Subjects Research
- Roles and Responsibilities
- Recruitment and Retention
- Institutional Review Boards (IRBs)
- Budget and Finance
- Informed Consent
- Adverse Events and Protocol Deviation
- Quality Assurance and Quality Control
- Regulatory File Maintenance
- Data Collection and Management
- Participants receive research regulations, ethics documents, and copies of all presentations, along with supplementary reading material and resources for independent learning outside of the class.
- The Fundamentals course includes access to the online "Orientation for Professional Resarch Staff" and the three-day onsite course.
- Breakfast and lunch are included for the three days of onsite instruction.
- Networking opportunities with other research staff and instructors.
Tuition does not cover the cost of accommodations. Several area hotels offer complimentary shuttle services or transportation vouchers to JHU.
Suggested Supplemental Articles
Gellman, R. (2010). Why deidentification fails research subjects and researchers. The American Journal of Bioethics, 10(9), 28-30.
Gover, W. (2005). All the easy experiments: A Berkeley professor, dirty bombs, and the birth of informed consent. Berkeley Science Review, 5(2), 41-5.
Hakimian, R., Korn, D. (2004). Ownership and use of tissue specimens for research. Journal of the American Medical Association, 292(20), 2500-5.
Levine, C., Sugarman, J. (2006). After the TGN1412 tragedy: Addressing the right questions at the right time for early phase testing. Hastings Center Bioethics Forum. Available at http://www.webcitation.org/5JyeyupEt (accessed on February 7, 2012).
McGraw, D. (2010). Data identifiability and privacy. The American Journal of Bioethics, 10(9), 30-1.
Kaiser Health News: NIH-sponsored AIDS drug trials "often" did not appoint advocates for foster child participants. (2005). Retrieved from http://sparkaction.org/resources/30188.
Onvomaha, T.P., Kass, N., Akweongo, P. (2006). The informed consent process in a rural African setting: A case study of the Kassena-Nankana district of Northern Ghana. IRB Ethics and Human Research, 28(3), 1-6.
Trinidad, S.B., Fullerton, S.M., Ludman, E.J., Jarvik, G.P., Larson, E.B., Burke, W. (2011). Research practice and participant preferences: The growing gulf. Science, 331(6015), 287-8.
Research Organizations at JHU
Research Staff Professional Organizations
Fundamentals Course Presenters
Linda Apuzzo BS, CCRC
Johns Hopkins Bloomberg School of Public Health (retired 6/2013)
From 1989 until her retirement in 2013 Linda Apuzzo worked in HIV clinical research at Johns Hopkins. Starting as a study coordinator in the School of Medicine and retiring as a faculty member in the School of Public Health, Linda has been involved in every aspect of clinical research from grant writing, development of budgets and assessment of staffing needs, protocol design, source document design, SOPs and regulatory document maintenance procedures, development of recruitment strategies, to study implementation including training study coordinators, quality assurance managers and other study staff. She has authored manuscripts and presented posters at international conferences. She directed a multicenter international clinical trial and trained and supervised coordinators at seven Canadian sites for whom she ran training seminars in study management and GCP. She has been involved with RCTP since 2005 and was part of a team which developed many of its early course offerings.
Liz Martinez RN, BSN, CCRC
Research Participant Advocate
Institute for Clinical and Translational Research
Johns Hopkins University
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 29 years of clinical research experience at Johns Hopkins University and has been a Certified Clinical Research Coordinator since 1998.
Mark R. Garcia
Institute for Clinical and Translational Research
Johns Hopkins University
Mark Garcia is the Administrative Director for the Johns Hopkins Institute for Clinical and Translational Research, an NIH-funded multidisciplinary institute dedicated to creating new models for conducting clinical and translational research by addressing critical obstacles that impede the progress of basic science discoveries to the clinic, clinical discoveries into the community, and results back to the research community.
Mr. Garcia has 20 years of nonprofit financial and administrative management experience and for the last 11 years has worked in administration and financial management for large private universities including the University of Pennsylvania and Johns Hopkins University. He has extensive experience managing pre- and post-award activities for a wide variety of sponsored projects including federally funded, privately funded, and industry funded clinical and pre-clinical research.
Tariq Syed, M.S, Pharm. D.
Sr. Research Subjects Specialist, JHSPH
Staff Drug Specialist, JHSPH
Clinical Research Pharmacist-IDS, BPRU (On Call)
Johns Hopkins University
Tariq Syed, Pharm D has worked as a Sr. Research Subjects Specialist, and Drug Specialist, for over 7 years at the Institutional Review Board (IRB) at the Johns Hopkins Bloomberg School of Public Health. He has taught the IRB section of the RCTP course from more than 4 years. Dr. Syed has extensive experience and working knowledge of both regulatory requirements and various pharmaceutical dosage forms. He also holds a Clinical Research Pharmacist (casual/on call) position at Behavioral Pharmacology Research Unit at Johns Hopkins Bayview Medical Center.
Prior to joining the JHSPH 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 is an active registered Pharmacist and Immunizer in the State of Maryland since May 2014.
Mark T. Hughes, M.D., M.A., F.A.C.P.
Assistant Professor of Medicine
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 co-director of the course, Introduction to Research Ethics, for graduate students in the School of Medicine.
Dina Lansey, BSN, MSN, RN, OCN
Department of Oncology
Johns Hopkins Medicine
Dina George Lansey is the Assistant Director of Diversity and Inclusion for Clinical Research in the Office of Community Cancer Research, at the Johns Hopkins Sidney Kimmel Comprehensive Cancer Center. A graduate of the Johns Hopkins School of Nursing and Drexel University College of Nursing and Health Professions, Dina has 18 years of oncology nursing experience. She has practiced in both pediatric and adult oncology delivering care to patients receiving standard of care and clinical trial treatments. In 2012, Dina was appointed faculty in the Johns Hopkins School of Medicine. She is responsible for initiating research to identify barriers, to clinical trial participation and developing interventions and policies which support diversity among trial participants.
Frederick W. Luthardt, D.Be., MA
Manager, Compliance Monitoring Program
Johns Hopkins University
School of Medicine
Office of Human Subjects Research
For my primary position, I manage 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 supervise on-site, routine monitoring and for-cause/directed audits of our human subjects research protocols. In this role I apply my knowledge of Federal regulations, Institutional requirements, and GCP Guidelines, to assess compliance at all applicable levels. Further, I work with investigators to identify deficiencies in regulatory compliance and a protocol's procedural conduct, in addition to generating corrective action mechanisms to maximize attention to a culture of 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 the Johns Hopkins Bayview Medical Center Clinical Research Unit. 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.
Refund and Cancellation Policy
Refunds, less a $50 processing fee, are provided to participants who cancel at least 30 days prior to a program offering. Requests to cancel received less than 30 days prior to a program will be offered registration in a substitute program, less a processing fee.
Note: If JHU tuition remission is used for payment, refunds will be provided until one week prior to the program.
Johns Hopkins University reserves the right to cancel a course due to low enrollments, in which event the enrollment fees for the course(s) will be refunded. If a course is canceled, applicants are notified immediately and are processed a full refund unless another course is requested.
Inclement Weather Policy
- When the university is open during inclement weather, all attempts will be made to hold scheduled programming.
- When the university is closed, all classes are cancelled.
- When the university opens late, a decision will be made regarding the course as appropriate. Notifications will be sent via e-mail to all participants as early as possible.
- Emergency Alerts, including weather related alerts, can be found by clicking the link "Emergency Alerts".
CNE Contact Hours
This 17.5 contact hour Educational Activity is co-provided by The Institute for Johns Hopkins Nursing and Johns Hopkins School of Nursing. The Institute for Johns Hopkins Nursing is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center’s Commission on Accreditation.
The Institute for Johns Hopkins Nursing and the American Nurses Credentialing Center do not endorse the use of any commercial products discussed or displayed in conjunction with this educational activity.
Upcoming Dates Open for Registration
Sept. 13-15, 2017
Jan. 10-12, 2018
May 9-11, 2018
Course runs 8:00 am - 5:00 pm each day
JHU School of Nursing
525 N. Wolfe Street,
Baltimore, MD 21205
Offered the First Friday of each month, webinars supplement knowledge gained in fundamentals course.
Includes the online orientation modules. Eligible for JHU Tuition Remission.