Associate Director OHSR
- Employer
- Johns Hopkins University
- Location
- Maryland, United States
- Salary
- Salary Not Specified
- Date posted
- Jan 13, 2022
View more
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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.
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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.
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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.
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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 atjhurecruitment@jhu.edu. For TTY users, call via Maryland Relay or dial 711.
Johns Hopkins has mandated COVID-19 and influenza vaccines, as applicable. Exceptions to the COVID and flu vaccine requirements may be provided to individuals for religious beliefs or medical reasons. Requests for an exception must be submitted to the JHU vaccination registry. For additional information, applicants for SOM positions should visit https://www.hopkinsmedicine.org/coronavirus/covid-19-vaccine/and all other JHU applicants should visit https://covidinfo.jhu.edu/health-safety/covid-vaccination-information/.
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.
Equal Opportunity
Employer
Note: Job Postings are updated daily and remain online until
filled.
EEO is the
Law
Learn more:
https://www.eeoc.gov/sites/default/files/migrated_files/employers/poster_screen_reader_optimized.pdf
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 jhurecruitment@jhu.edu. For TTY users, call via Maryland Relay or dial 711.
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.
Equal Opportunity Employer
Note: Job Postings are updated daily and remain online until filled.
EEO is the Law
Learn more:
https://www1.eeoc.gov/employers/upload/eeoc_self_print_poster.pdf
Important legal information
http://hrnt.jhu.edu/legal.cfm
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