The Office of Human Subjects Research is seeking a Director of Compliance for the SOM Office of Human Subjects Research (OHSR) has primary 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 JHHS' Federalwide Assurances). The Director will manage the OHSR compliance team and is responsible for designing and coordinating the strategic and daily compliance activities of the OHSR. As an active member of the OHSR leadership team, the Director will work closely with the Vice Dean for Clinical Investigation, the Associate Dean for Human Research Protections, JHU and JHHS counsels, OHSR Director of Operations, Institutional Review Board (IRB) Chairs and Members, leaders from the Office of Research Administration (ORA), Office of Policy Coordination (OPC), HIPAA Privacy Office, and other relevant institutional committees and offices.
The position will report to the Associate Dean for Human Research Protections. The Director will work closely with the Vice Dean for Clinical Investigation, JHU/JHHS counsel and the OHSR Director of Operations.
Specific Duties & Responsibilities:
Develop and implement institutional policies and procedures to ensure compliance with federal, state and local regulations and guidelines as they relate to human subjects' research.
Develop, implement, and analyze systems to monitor the human research review process including the interpretation and application of all aspects of pertinent government regulations.
Manage the OHSR Human Research Compliance Associates. Ensure that regular performance feedback and appropriate training is provided to all compliance staff.
Oversight of preparation of OHRP and FDA reports of serious or continuing non-compliance or unanticipated problems involving risks to participants or others. Assign compliance team member (when necessary) to draft reports. Coordinate review process with the Associate Dean, General Counsels and the Vice Dean for Clinical Investigation. Track reports sent and responses received from federal agencies.
Assign compliance team coverage for convened meetings in conjunction with the Associate Director of Compliance.
Attend IRB meetings to provide regulatory expertise, monitor proceedings and assist staff with regulatory documentation issues.
Provide on-going regulatory advice to the IRBs and JHM 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.
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. Serve as an IRB member to review and approve relevant single IRB applications and amendments when appropriate. Responsible for training Human Research Compliance Associates and other OHSR team members on the review of external IRB applications and relying site applications.
Work with the Associate Dean and Director of Operations to ensure that new entities joining Johns Hopkins Medicine are integrated into the OHSR systems and continually monitor the integration to ensure a smooth transition.
Work with the Associate Dean and Director of Operations to ensure that Clinical Research Network sites are integrated into the OHSR systems and continually monitor the integration to ensure a smooth transition.
Perform pre-view of documents submitted with 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 required HIPAA forms.
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.
Review and confirm documentation on IND and IDE status of products used in research applications reviewed by the IRBs.
Responsible for evaluating the OHSR compliance programs and continually refining the structure, policy and processes to meet required outcomes.
Assume a lead role in the accreditation renewal process with the Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP).
Assume a lead role in US Food and Drug Administration IRB inspection visits and Office of Human Research Protection (OHRP) visits.
Develop and lead educational offerings for OHSR staff, IRB members and Chairs, JHM research teams.
Participate in national initiatives related to human research protections.
Participate in regular meetings with Research Environment Systems to assist in the identification of electronic submission system deficiencies.
Work as part of a team to develop and test solutions to correct system deficiencies. Help with development of immediate strategies to mitigate non-compliance related to system issues.
Serve as a back-up to address regulatory issues in the absence of the Associate Dean for Human Research Protections.
Perform other duties as required related to human subject research practice or compliance, as requested by the Vice Dean for Clinical Investigation or Associate Dean.
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):
Bachelors 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 5 years of experience relevant to the planning, conducting or administration of human subjects research required.
Minimum of 3 years supervisory experience required.
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.
Assume a leadership role when working as part of a team, ability to communicate effectively, set an example of workplace engagement.
Experience in group process and dynamics is valuable in this position.
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.
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.
Classified Title: Director Compliance Operations Working Title: Director Compliance Operations, SOM Office of Human Subjects Research Role/Level/Range: L/04/LF Starting Salary Range: $92,570 - $127,270 annually (commensurate with experience) Employee group: Full Time Schedule: M-F 8:30 - 5:00 Exempt Status: Exempt Location: ???????School of Medicine Campus Department name: ???????SOM Admin Clinical Invest Human Subjects Personnel area: School of Medicine
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