Human Research Compliance Associate

The Office of Human Subjects Research is seeking a Human Research Compliance Associate to provide regulatory and compliance advice to the Johns Hopkins University Institutional Review Boards (JHU IRBs). This includes applicable federal, state, and local laws and regulations and institutional policies relating to the protection of human subjects in research conducted at or through JHU.

Specific Duties & Responsibilities

• Interpret and apply all aspects of pertinent government regulations and institutional policies pertaining to human subjects research and related matters.
• Review applications submitted to the IRBs to identify deficiencies under federal and state laws and regulations, and institutional policies that must be corrected prior to IRB review.
• Determine that appropriate protocol- and application-specific documentation is submitted, e.g., requests for waiver of consent, waiver of HIPAA authorizations, formal communications from the FDA or commercial sponsors.
• Assist in the review of IRB action outcomes, including the IRB’s minutes where required, and determine that regulatory, legal, and policy issues and their outcomes are documented appropriately.
• Attend weekly IRB meetings to provide regulatory expertise, monitor proceedings, and assist staff with regulatory documentation issues.
• Provide ongoing regulatory advice to JHU IRBs and JHU investigators and study team members.
• Lead regulatory consults with faculty to assist with protocol planning and addressing complex regulatory issues that may arise as part of the IRB submission and review process.
• Develop and lead educational offerings for IRB staff, IRB members and Chairs, and JHU research teams.
• Prepare reports of serious non-compliance, continuing non-compliance, or unanticipated problems involving risks to participants or others.
• Independently review select research applications, e.g. new applications, further study actions, relevant single IRB applications, as an IRB member and work with faculty/research staff to identify deficiencies to correct prior to IRB approval.
• Other duties as assigned.

Minimum Qualifications

• Juris Doctor (JD) from an accredited law school.
• Member of the Bar of the State of Maryland in good standing (or admitted to the bar of another state), or eligible to sit for the bar exam; continued employment is contingent upon passing the bar exam within one year of start date.

Preferred Qualifications

• Three years of compliance or administrative experience related to human subjects research.