The Human Research Compliance Associate (the "Associate") 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 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 staffs, 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.
Primary Duties and Responsibilities:
The Associate, in cooperation with relevant staff and institutional officials (including Counsels for JHU and JHHS, and the Assistant Dean for Human Research Protections), will work to interpret and apply all aspects of pertinent government regulations and institutional policies pertaining to human subjects 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.
He/she 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.
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).
Minimum of 3 years of compliance or administrative experience relevant to human research studies is highly desirable.
The position will report to the Associate Director of Compliance in the Office of Human Subjects Research (OHSR).
The Associate also will work closely with the Director of Compliance, the Assistant Dean for Human Research Protections, General Counsels for JHU and JHHS, and the Vice Dean for Clinical Investigation.
Familiarity with the regulatory agencies involved in human research and pertinent laws and regulations as well as the ethical considerations related to that subject highly desirable The Associate must have the ability to apply regulatory requirements to proposed research protocols, exhibit skills in conducting research using electronic methods, and possess exemplary writing and verbal skills. Experience in group process and dynamics is valuable in this position.
Sitting in a normal seated position for extended periods of time.
Reaching by extending hand(s) or arm(s) in any direction.
Finger dexterity 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.
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.
Classified Title: Human Research Compliance Associate Role/Level/Range: ATP/04/PE Starting Salary Range: $69,140 - $95,005 commensurate with experience Employee group: Full Time Schedule: M-F 8:30 am - 5:00 pm Exempt Status: Exempt Location: 04-MD:School of Medicine Campus Department name: 10002712-SOM Admin Clinical Invest Human Subjects Personnel area: School of Medicine
The successful candidate(s) for this position will be subject to a pre-employment background check.
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The following additional provisions may apply depending on which campus you will work. Your recruiter will advise accordingly.
During the Influenza ("the flu") season, as a condition of employment, The Johns Hopkins Institutions require all employees who provide ongoing services to patients or work in patient care or clinical care areas to have an annual influenza vaccination or possess an approved medical or religious exception. Failure to meet this requirement may result in termination of employment.
The pre-employment physical for positions in clinical areas, laboratories, working with research subjects, or involving community contact requires documentation of immune status against Rubella (German measles), Rubeola (Measles), Mumps, Varicella (chickenpox), Hepatitis B and documentation of having received the Tdap (Tetanus, diphtheria, pertussis) vaccination. This may include documentation of having two (2) MMR vaccines; two (2) Varicella vaccines; or antibody status to these diseases from laboratory testing. Blood tests for immunities to these diseases are ordinarily included in the pre-employment physical exam except for those employees who provide results of blood tests or immunization documentation from their own health care providers. Any vaccinations required for these diseases will be given at no cost in our Occupational Health office.
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