We are seeking an Associate Director for the SOM Office of Human Subjects Research (OHSR) will assist the Director of Compliance (Director) with the responsibility for OHSR compliance with applicable federal, state and local laws and regulations and institutional policies relating to the protection of human subjects in research conducted at or through Johns Hopkins Medicine (collectively referring to The Johns Hopkins University and all institutions included in the School of Medicine and the JHHS' Federalwide Assurances).
The Associate Director directly supervises the OHSR Human Research Compliance Associates (Compliance Associates) and has primary responsible for the day-to-day management and training of the Compliance Associates. The Associate Director will serve as the lead compliance team liaison for the development of OHRP policies, procedures and SOPs and will assume a lead role in addressing compliance issues for single IRB studies, both for studies involving reliance of external sites on the JHM IRBs and reliance by JHM on external IRBs.
As an active member of the OHSR leadership team, the Associate Director will work closely with the Associate Dean for Human Research Protections (Associate Dean), JHU and JHHS counsels, the OHSR management team, Institutional Review Board (IRB) Chairs and Members, and leaders from across the Human Research Protections Program (HRPP) to maintain and advance the compliance efforts of the JHM HRPP. The position will report to the Director. The Associate Director also will work closely with the Associate Dean.
Specific Duties & Responsibilities:
Assist the Director in the development, implementation and on-going evaluation of institutional policies, procedures and processes to ensure compliance with federal, state and local regulations and guidelines as they related to human subjects research.
With the input of the Director, serve as the direct supervisor for the Compliance Associates. This will include handling day-to-day operations such as assigning compliance team coverage for convened IRB meetings, training Compliance Associates, seeking opportunities for growth, and addressing questions.
With the input of the Director, serve as the lead in conducting and documenting performance reviews for the Compliance Associates.
With the input of the Director, serve as the lead in training new and current Compliance Associates with the goal of maintaining consistence and accuracy among team members.
With the input of the Director, serve as the lead point person/liaison for the development of OHRP policies, procedures and SOPs.
With the input of the Director, serve as the lead point person/liaison for single IRB studies, both for studies involving reliance of external sites on the JHM IRBs and reliance by JHM on external IRBs. Assume a lead role in training Compliance Associates and other OHSR team members on the review of external IRB applications and relying site applications.
Provide on-going regulatory advice to JHM IRBs and JHM investigators and study team members.
Perform pre-review of documents submitted with IRB applications and work with investigators and study team members to identify deficiencies to be corrected prior to IRB review. Assure that appropriate protocol-specific documentation is submitted with requests for waiver of consent, waiver of HIPAA authorization, and additional HIPAA forms.
Review and confirm documentation on IND and IDE status of products used in research applications reviewed by the IRBs.
Attend IRB meetings to provide regulatory expertise, monitor proceedings and assist staff with regulatory documentation issues.
Review and revise IRB minutes and letters following assigned IRB meetings.
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.
Serve as an IRB member to review and approve relevant single IRB applications and amendments when appropriate.
Develop and lead educational offerings for OHSR staff, IRB members and Chairs, and JHM research teams.
Prepare OHRP and FDA reports of serious non-compliance, continuing non-compliance or unanticipated problems involving risks to participants or others.
Independently conduct review of select research applications (new applications and further study actions) as an IRB member and work with faculty/research staff to identify deficiencies needing correction prior to IRB approval.
Assist the Director in the accreditation renewal process with the Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP).
Assist the Director in U.S. Food and Drug Administration IRB inspections visits of Hopkins' investigators and OHSR, and Office of Human Research Protection (OHRP) visits.
Serve as a back-up to address regulatory issues in the absence of the Director.
Perform other duties as required related to human subjects research practice, as requested by the Associate Dean or the Director.
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.
Minimum Qualifications (Mandatory):
Bachelor's Degree from an accredited 4-year college, plus 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 the District of Columbia).
Minimum of 3 years of experience relevant to the planning, conducting or administration of human subjects research required.
Minimum of 2 years supervisory experience or a minimum of 2 years in a senior compliance role in a HRPP program of similar size required.
* Applicants who do not meet the posted requirements but are completing their final academic semester/quarter will be considered eligible for employment and may be asked to provide additional information confirming their academic completion date.
Special Knowledge, Skills & Abilities:
Must be familiar with the regulatory agencies involved in human research and pertinent laws and regulations, and must be conversant with ethical considerations related to that subject.
Must have the ability to apply regulatory requirements to proposed research protocols, and exhibit computer research skills and exemplary writing and verbal skills.
Should assume a leadership role when working as part of a team, have the ability to communicate effectively, and set an example of workplace engagement.
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.
Remote Work Designation:
This position has been designated as a remote position.
On-site attendance may be required for select meetings or events. Advanced notice will be provided for these circumstances.
Classified Title: Associate Director OHSR Role/Level/Range: ATP/04/PF Starting Salary Range: Commensurate with experience Employee group: Full Time Schedule: M-F 8:30 - 5:00 Exempt Status: Exempt Location: Telecommute Department name: 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.
If you are interested in applying for employment with The Johns Hopkins University and require special assistance or accommodation during any part of the pre-employment process, please contact the HR Business Services Office at [email protected]. For TTY users, call via Maryland Relay or dial 711.
The following additional provisions may apply, depending on campus. Your recruiter will advise accordingly.
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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