Departtment: Institute for Clinical and Translational Research
Work Schedule/Hours: Monday-Friday/8:30-5p/37.5 hrs.
Clinical research trials are required to be registered and reported in a publically-accessible database under Section 801 of the Food and Drug Administration Amendments Act (FDAAA). This database is called ClinicalTrials.gov. This position within the Institute for Clinical and Translational Research (ICTR) will administer the program to ensure adherence to the Federal regulation relating to the registration and reporting of clinical research across the Johns Hopkins University, School of Medicine. This individual will report to and work closely with the Director of the Johns Hopkins University ClinicalTrials.gov Program (Program) to develop mechanisms that will ensure ethical standards, scientific integrity and regulatory compliance with ClinicalTrials.gov. This work will involve writing Standard Operating Procedures (SOPs), developing training programs and substantial communication with research program coordinators, research nurses, and/or Principal Investigators (PI) to register, update and report results for all research studies deemed applicable clinical trials.
Duties & Responsibilities
Using knowledge of applicable laws and regulations, this individual provides guidance on interpretation for clinical trials registration requirements, including those of FDAAA, International Committee of Medical Journal Editors (ICMJE), Center for Medicare and Medicaid Services (CMS), and National Institutes of Health (NIH).
Works with the Office of Human Subjects Research – Institutional Review Boards (IRB) to ensure that all applicable clinical research trials are included in this program. It includes receiving and responding to notifications and monthly reports.
Provides guidance and support to the research community regarding the registration and reporting requirements for all clinical research.
Manage access and maintenance of ClinicalTrials.gov system for JHU SOM. This includes ensuring that individuals have access to onl trials that they are working, and lose access as appropriate.
Ensures compliance with registration and results disclosure requirements, and escalates to applicable Research Compliance and/or Institutional Officials as outlined by the program
Develops and conducts educational training programs related to Clinical Trials transparency to investigators, study teams, and institutional leadership on an ongoing basis.
Prepares reports to keep institutional leadership updated via reporting of compliance rates and activities. Analyzes project data and prepares data for reports and presentations inside and outside the institution
Manages and updates the Program’s institutional website to ensure it has the latest information on regulatory requirements, links to recent trainings, and links to relevant publications and websites.
Provides one-on-one assistance for investigator initiated trials requiring results reporting. Works with investigators to enter information into ClincalTrials.gov.
Develops and maintains a system to prospectively identify and track studies with required results reporting.
Researches and brings retrospective studies into compliance where investigators are no longer available.
Actively participates and engages in the National Clinical Trials Registration Taskforce – a monthly meeting of clinical trial registration experts at Academic Medical Centers (AMC) focusing on clinical trials registration and results reporting issues that affect AMCs. Over time, may take on leadership roles in this group.
Initiates and participates in collaborations with key stakeholders within JHU and at other academic research institutions relating to best practices, quality improvement projects, SOPs, work processes, and knowledge and experiences.
Writes and/or presents abstracts, posters for publications.
Performs literature reviews, and keeps current on national and international policies that may affect the Program
Develop and maintain a database to track interactions for specific research studies so that information is available to everyone working in the office. .
Oversees and participates in special event planning for Program activities.
Performs other duties as required.
Bachelor’s degree in one of biological or social sciences, or other related discipline. Some statistical coursework required and a minimum of three years of experience doing clinical research, working with data collection and analysis. Prior working experience in data collection methodology required.
Required: Master’s degree in one of biological sciences, social sciences, public health, or other related discipline, and a minimum of one year related experience of experience doing clinical research, working with data collection and analysis. Prior working experience in data collection methodology required.
Certified Clinical Research Professional (CCRP) or Certified Clinical Research Coordinator (CCRC)
Johns Hopkins University remains committed to its founding principle, that education for all students should be grounded in exploration and discovery. Hopkins students are challenged not just to learn but also to advance learning itself. Critical thinking, problem solving, creativity, and entrepreneurship are all encouraged and nourished in this unique educational environment. After more than 130... years, Johns Hopkins remains a world leader in both teaching and research. Faculty members and their research colleagues at the university's Applied Physics Laboratory have each year since 1979 won Johns Hopkins more federal research and development funding than any other university. The university has nine academic divisions and campuses throughout the Baltimore-Washington area. The Krieger School of Arts and Sciences, the Whiting School of Engineering, the School of Education and the Carey Business School are based at the Homewood campus in northern Baltimore. The schools of Medicine, Public Health, and Nursing share a campus in east Baltimore with The Johns Hopkins Hospital. The Peabody Institute, a leading professional school of music, is located on Mount Vernon Place in downtown Baltimore. The Paul H. Nitze School of Advanced International Studies is located in Washington's Dupont Circle area.