Human Research Compliance Associate
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About The Position
The Office of Human Subjects Research at Johns Hopkins University is seeking a Human Research Compliance Associate for a fully remote position. This role is pivotal in providing regulatory and compliance advice on a daily basis to the Johns Hopkins Medicine Institutional Review Boards (JHM IRBs). The Associate will ensure adherence to applicable federal, state, and local laws and regulations, as well as institutional policies that protect human subjects involved in research conducted at or through JHM. This encompasses all institutions included in the JHU School of Medicine's and the JHHS's Federal Wide Assurances. The Associate will also extend their expertise to JHM investigators, their research staff, and other members of the broader JHM human subjects research community, including researchers at non-Hopkins sites that rely on the review of the JHM IRBs. In collaboration with relevant staff and institutional officials, including Counsels for JHU and JHHS, and the Associate Dean for Human Research Protections, the Associate will interpret and apply all aspects of pertinent government regulations and institutional policies related to human subjects research. Responsibilities include reviewing applications submitted to the IRBs to identify deficiencies under federal and state laws and regulations, ensuring that appropriate protocol- and application-specific documentation is submitted, and assisting in the review of IRB action outcomes. The Associate will attend weekly IRB meetings to provide regulatory expertise, monitor proceedings, and assist staff with regulatory documentation issues. Additionally, the Associate will lead regulatory consultations with faculty to assist with protocol planning and address complex regulatory issues that may arise during the IRB submission and review process. They will also develop and lead educational offerings for OHSR staff, IRB members and Chairs, and JHM research teams. The Associate will prepare reports for the OHRP and FDA regarding serious non-compliance, continuing non-compliance, or unanticipated problems involving risks to participants or others. This position requires a strong ability to work independently, exercise sound judgment, and manage multiple tasks effectively in a fast-paced environment.
