the Senior Human Subjects Research Specialist will support the Office of Human Research Administration (OHRA), a division of the Research Administration Department. The Specialist will be the point person for a team to facilitate preparation and submission of human subjects research documentation for submission to external Institutional Review Boards (IRB). The individual is responsible for assisting with completing and tracking necessary documentation and reviewing processes to ensure that research activities follow best practices and comply with ethical, regulatory, and legal requirements.
- Works with minimum supervision to provide administrative and regulatory support and guidance regarding human subjects research applications submitted to the Johns Hopkins Medicine IRB.
- Advises and assists investigators and research personnel regarding the preparation of human subjects research applications in accordance with institutional, local, state, and federal policies and regulations.
- Conducts administrative review of designated human subjects research application submissions, communicates required and recommended revisions to investigators, and routes applications to ancillary reviews and IRB when appropriate.
- Coordinates OHRA’s Data Use and Security ancillary review committee and assists in the coordination of other committees including Outside Interests, Research Ethics, and High-Risk Research as needed.
- Develops and maintains thorough Institutional documentation, records, and databases related to human subjects research.
- Documents and tracks research application action items to closure, including completion of administrative reviews, communication with other offices and committees, and IRB approval of applications.
- Generates timely and critical reports for departmental and senior leadership as requested.
- Provides assistance with the development, documentation, and revision of policies, procedures, training materials, and instructions.
- Assists with training investigators and research personnel on human research protections, research data management, and responsible conduct of research.
- Assists on other projects as needed.
- Bachelor’s degree required.
- Graduate level training can substitute for up to two years of related experience.
- Relevant certification such as Certified IRB Professional (CIP ®) is a plus.
- A minimum of 3 years of related experience in the conduct, compliance, and/or administration of human subjects research are required.
- Experience preparing human subject research applications is strongly preferred.
- Experience with IRB operations is a plus.