Human Research Compliance Associate (Office of Human Subjects Research)

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.
• Affiliate with the review of IRB action outcomes, including the IRB's minutes where required, and ensure 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 address 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.

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.
• 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

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