Human Research Compliance Associate

The Office of Human Subjects Research is seeking a Human Research Compliance Associate. This fully remote position will be responsible for providing regulatory and compliance advice on a day-to-day basis to the Johns Hopkins Medicine Institutional Review Boards (JHM IRBs). This will be with respect to applicable federal, state, and local laws and regulations and institutional policies relating to the protection of human subjects in research conducted at or through JHM (collectively referring to The Johns Hopkins University and all institutions included in the JHU School of Medicine’s and the JHHS’s Federal Wide Assurances). The Associate will also be responsible for providing this advice to JHM investigators, their research staff, and other members of the broader JHM human subjects research community, including researchers at non-Hopkins sites relying on the review of the JHM IRBs.

This position has been designated as a 100% remote position. On-site attendance may be required for select meetings or events. Advanced notice will be provided for these circumstances.

Specific Duties & Responsibilities

• The Associate, in cooperation with relevant staff and institutional officials (including Counsels for JHU and JHHS, and the Associate Dean for Human Research Protections), will work to interpret and apply all aspects of pertinent government regulations and institutional policies pertaining to human subject's research and related matters.
• The Associate will 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.
• The Associate will 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.
• The Associate will 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.
• The Associate will attend weekly IRB meetings to provide regulatory expertise, monitor proceedings, and assist staff with regulatory documentation issues.
• The Associate will provide on-going regulatory advice to JHM IRBs and JHM investigators and study team members.
• The Associate will 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.
• The Associate will develop and lead educational offerings for OHSR staff, IRB members and Chairs, and JHM research teams.
• The Associate will prepare OHRP and FDA reports of serious non-compliance, continuing non-compliance, or unanticipated problems involving risks to participants or others.
• The Associate will independently conduct a review of select research applications (new applications, further study actions, relevant single IRB applications) as an IRB member and work with faculty/research staff to identify deficiencies needing correction prior to IRB approval.
• Perform other duties as required related to human subject's research practice, as requested by the Associate Dean or the Director.

Skills

• Familiarity with the regulatory agencies involved in human research and pertinent laws and regulations, as well as the ethical considerations related to that subject.
• The Associate must have the ability to apply regulatory requirements to proposed research protocols, exhibit skills in conducting research using electronic methods.
• Good analytical and writing skills.
• Knowledge of the ethical principles and regulations relevant to human subject's research and IRB processes.
• Demonstrated ability to work independently, exercise sound judgment, and multi-task.
• Excellent written and verbal communication skills.
• Ability to communicate in a professional, positive, and persuasive manner.
• Ability to work as a team member, be very detail-oriented, and communicate with faculty and staff both internal and external to the institution at all levels.
• Strong administrative/coordination skills.
• Experience in high volume office and ability to meet time sensitive processing deadlines. Ability to work in a fast-paced and demanding environment and able to manage multiple tasks effectively.

Physical Requirements

• Sitting in a normal seated position for extended periods of time.
• Reaching by extending hand(s) or arm(s) in any direction.
• Finger dexterity is required to manipulate objects with fingers rather than with whole hand(s) or arm(s), for example, using a keyboard.
• Communication skills using the spoken word.
• Ability to see within normal parameters.
• Ability to hear within normal range.
• Ability to move about, including transportation of a laptop computer and files.
  
  

*This description is a general statement of required major duties and responsibilities performed on a regular and continuous basis. It does not exclude other duties as assigned.

• J.D. from an accredited law school and a 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.
• The individual must pass the Bar exam within 1 year of employment.

• Minimum of 3 years of compliance or administrative experience relevant to human research studies is highly desirable.

Classified Title: Human Research Compliance Associate

Role/Level/Range: ATP/04/PE

Starting Salary Range: $73,300 - $128,300 Annually ($85,000 targeted; Commensurate with experience)
Employee group: Full Time
Schedule: Mon - Fri 8:30am - 5:00pm
Exempt Status: Exempt
Location: Remote
Department name: SOM Admin Clinical Invest Human Subjects

Personnel area: School of Medicine