IRB Program Manager
Company: All Children's Hospital
Location: Saint Petersburg
Posted on: October 12, 2019
IRB Program Manager Requisition #: 177902
Location: Johns Hopkins All Children's Hospital, St. Petersburg, FL
Work Shift: Day Shift
Work Week: Full Time (40 hours)
Weekend Work Required: No
Date Posted: July 11, 2019
Johns Hopkins Health System employs more than 20,000 people
annually. Upon joining Johns Hopkins Health System, you become part
of a diverse organization dedicated to its patients, their
families, and the community we serve, as well as to our employees.
Career opportunities are available in academic and community
hospital settings, home care services, physician practices,
international affiliate locations and in the health insurance
industry. If you share in our vision, mission and values and also
have exceptional customer service and technical skills, we invite
you to join those who are leaders and innovators in the healthcare
Johns Hopkins Medicine (JHM) is a world leader in basic, clinical
and translational research and medical and graduate school
training. The JHM Institutional Review Boards (IRBs) oversee the
review and approval of a research portfolio of approximately 8000
active protocols, including research conducted through the Johns
Hopkins University Schools of Medicine and Nursing and the Johns
Hopkins Health System. The JHACH IRB Program is a core component of
the Johns Hopkins Medicine (JHM) Human Research Protection Program
(HRPP), and the JHACH IRB is one of JHM's seven IRBs. The Manager
of the Johns Hopkins All Children's Hospital (JHACH) IRB Program is
responsible for oversight of the operations of the JHACH IRB
Program, including the JHACH IRB Committee.
Established nearly a century ago as the ???American Legion Hospital
for Crippled Children??? (providing care, rehabilitation, and
educational services for children with polio and other debilitating
disorders), JHACH is now a regional pediatric referral center for
Florida's West Coast and beyond, and is nationally ranked among the
top 50 children's hospitals by U.S. News & World Report in five
specialties. Located in the beautiful and vibrant downtown of St.
Petersburg, FL (within short driving distance of Tampa, Clearwater,
Orlando, and Sarasota), JHACH is home to an ACGME-accredited
Pediatric Residency Program and a growing number of pediatric
medical and surgical subspecialty Fellowship programs. JHACH
investigators conduct and/or participate in over 350 clinical
research studies annually, including approximately 50 FDA-regulated
drug and device trials. JHACH also serves as the Clinical
Coordinating Center for several investigator-initiated (including
National Institutes of Health-funded) clinical research studies in
which JHACH clinical investigators serve as overall/multicenter
principal investigators. JHACH is also home to several cutting-edge
basic science programs, with a focus on interdisciplinary science
that advances pediatric medicine by bringing together these basic
scientists with clinical/ translational investigators and
clinicians from a broad array of subspecialties and subject matter
Leveraging the support of the broader JHM HRPP infrastructure, the
JHACH IRB Program Manager is responsible for both leading the JHACH
IRB Program and supporting the JHACH research community in the
compliant and ethical conduct of research.
This position reports to the JHM Assistant Dean for Human Research
Protection, and the JHM Associate Dean for Research at JHACH.
- Coordinates the implementation of routine JHACH IRB program
procedures in an operationally and fiscally responsible manner, and
monitors compliance to these procedures in support of the JHM IRB
review process, in conjunction with the Assistant Dean for Human
Research Protection for the Office of Human Subjects Research
- Represents the JHACH IRB Program on institutional committees
and workgroups related to human subjects research activities at
JHACH, and serves as the JHACH IRB Program liaison on committees
constituted to improve the functioning of the overall JHM HRPP.
- Works with the JHACH IRB Chair, JHACH IRB Members and staff of
the JHM OHSR to support the ethical review and oversight of
protocols assigned for review by the JHACH IRB.
- Provides daily supervision to the staff of the JHACH IRB
Program, including the Senior Research Subject Specialist and IRB
- Facilitates IRB investigations of noncompliance or
unanticipated events involving risks to subjects or others related
to research conducted at JHACH, and ensures appropriate follow-up
with IRB required actions in collaboration with JHM OHSR.
- Serves as a resource for investigators and study team members
with regard to regulatory and compliance issues related to human
- Oversees preparation of reports of JHACH IRB Program activities
for presentation by the Associate Dean for Research at JHACH to
institutional governance bodies (e.g., Boards of
- Collaborates with the Associate Dean for Research at JHACH, the
Manager of Research Regulatory Affairs/Quality Assurance within the
JHAC Clinical and Translational Research Organization, and the JHM
Assistant Dean for Human Research Protections to develop clinical
research education/training modules for JHACH investigators and
research staff that are adjunctive to the education/training
resources provided via JHM OHSR.
- Exercises sound judgement and assumes responsibility for
answering inquiries that have a direct impact on the review process
of human subjects research protocols.
- Ensures continual compliance with regulatory standards.
- Bachelor's degree in appropriate discipline (e.g. nursing,
social sciences, allied heath profession)
- 2-5 years of management experience,
- Minimum of five years of relevant work experience with IRBs
and/or clinical research
- Knowledge of ethical principles, regulations, policies and
procedural requirements pertaining to human subjects research and
- Strong supervisory, administrative, coordination, and
- Strong writing skills; effective communication, presentation
and facilitation skills
- Highly organized and detail-oriented. Preferred
- Advanced degree (e.g., Master's).
- Regulatory/compliance experience desired.
- Professional certification in human subjects research/human
research protection (e.g. SOCRA, CIP).
- Management experience in an academic health center/system
setting. Johns Hopkins Health System and its affiliates are
drug-free workplace employers.
Johns Hopkins Health System and its affiliates are an Equal
Opportunity / Affirmative Action employers. All qualified
applicants will receive consideration for employment without regard
to race, color, religion, sex, sexual orientation, gender identity
and expression, age, national origin, mental or physical
disability, genetic information, veteran status, or any other
status protected by federal, state, or local law.
All Children's Hospital provides expert pediatric care for children
and families from all across the state of Florida and beyond. Named
a top 50 children's hospital by U.S. News & World Report,--we
provide compassionate, state-of-the-art care for infants, children
and teens with some of the most challenging medical problems. We
are a 259-bed pediatric hospital.--
Keywords: All Children's Hospital, St. Petersburg , IRB Program Manager, Executive , Saint Petersburg, Florida
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