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The Office of Human Subjects Research is seeking a JH-ACH IRB Program Manager. The JH-ACH IRB Program Manager is responsible for oversight of the operations of the JHACH IRB Program, including the JHACH IRB Committee. As a member of the OHSR management team, the JH-ACH IRB Program Manager works closely with the Director OHSR Operations, Associate Directors of Convened and Exempt/Expedited Review, Director of Compliance, the Associate Dean for Human Research Protections Program, the IRB Chairs, and operational leaders across the Human Research Protections Program to maintain and advance efficient processing of human subject research projects at the Johns Hopkins School of Medicine.
Specific Duties & Responsibilities
- In conjunction with the OHSR Directors and OHSR management team, plan and coordinate activities in support of the OHSR IRB review processes.
- Represent the JHACH IRB Program on institutional committees and workgroups related to human subjects research activities at JHACH; serves as the JHACH IRB Program liaison on committees constituted to improve the functioning of the overall Johns Hopkins Medicine Human Research Protections Program.
- Work with the IRB Chair, IRB Members, and staff of the JHM OHSR to support the ethical review and oversight of protocols assigned to the JHACH IRB for review.
- Provide daily supervision to the staff of the JHACH IRB Program, including the IRB Analyst and Consent Form Specialist.
- Facilitate IRB investigations of noncompliance or unanticipated events involving risks to subjects or others related to research conducted at JHACH and ensures appropriate follow-up with IRB required actions in collaboration with JHM OHSR.
- Oversee preparation of reports of JHACH IRB Program activities for presentation by the JHACH Director of Research to institutional governance bodies (e.g., Executive Committee of JHACH and JHACF).
- Analyze workflows to determine the most efficient and effective processes and assist with the development and implementation of improved workflows as needed.
- Lead consultations with research teams and serve as a resource for investigators and study teams to assist with protocol planning and addressing complex operational and regulatory issues that may arise as part of the IRB submission and review process.
- On a regular and continuous basis, exercise sound judgment and assume responsibility for answering inquiries that have a direct impact on the review process of human subject research protocols.
- Participate in the revision and development of OHSR review guidelines, policies, FAQs, forms, and templates.
- Contribute to US Food and Drug Administration IRB inspection visits and Office of Human Research Protection (OHRP) visits.
- Develop and lead educational offerings for OHSR staff, IRB members and Chairs, JHM research teams, and the broader HRPP community, including targeted trainings for the JHACH research community.
- Participate in HRPP evaluation, strategic planning, and the formulation of short- and long-term goals and objectives.
- Determine congruency of grants with approved protocols using standards established by federal regulations and institutional policy.
- Attend IRB meetings to provide regulatory expertise, monitor proceedings, and assist staff with regulatory documentation issues.
- Review and revise IRB minutes and letters following assigned IRB meetings.
- Prepare OHRP and FDA reports of serious non-compliance, continuing non-compliance, or unanticipated problems involving risks to participants or others.
- Independently conduct review of select research applications (new applications and further study actions) as an IRB member and work with faculty/research staff to identify deficiencies needing correction prior to IRB approval.
- Other duties as assigned related to human subjects research practice, as requested by the Associate Dean.
Remote Work Designation
- This position has been designated as remote; however, the individual in this role will be expected to travel several times each year for required in-person meetings and related events. Advance notice will be provided whenever possible.
Minimum Qualifications
- Bachelor's Degree.
- Five years of experience relevant to the planning, conducting or administration of human subjects research.
- Two years of supervisory experience, preferably within an academic medical environment.
- Additional education may substitute for required experience and additional related experience may substitute for required education beyond a high school diploma/ graduation equivalent, to the extent permitted by the JHU equivalency formula.
Preferred Qualifications
- Advanced Degree
Classified Title: Associate Director OHSR
Job Posting Title (Working Title): JH-ACH IRB Program Manager (Office of Human Subjects Research
Role/Level/Range: ATP/04/PF
Starting Salary Range: $85,500 - $149,800 Annually ($95,000 targeted; Commensurate w/exp.)
Employee group: Full Time
Schedule: Monday - Friday 8:30 am - 5:00pm
FLSA Status: Exempt
Location: Remote
Department name: SOM Admin Clinical Invest Human Subjects
Personnel area: School of Medicine
