IRB Program Manager
Requisition #: 177902
Location: Johns Hopkins All Children's Hospital, St. Petersburg, FL 33701
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 field.
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 expertise.
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 (OHSR).
- 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 Monitoring Specialist.
- 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 subject research.
- 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 Trustees).
- 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 IRBs
- Strong supervisory, administrative, coordination, and managerial skills
- Strong writing skills; effective communication, presentation and facilitation skills
- Highly organized and detail-oriented.
- 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.
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