109155 - IRB Principal Analyst (Pediatrics)
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#109155 IRB Principal Analyst (Pediatrics)Filing Deadline: Fri 10/8/2021
For the safety and well-being of the entire university community, the University of California requires, with few exceptions, that all students, faculty and staff be vaccinated against the COVID-19 virus before they will be allowed on campus or in a facility or office. For more information visit: https://ucnet.universityofcalifornia.edu/news/2021/07/ucs-covid-19-vaccine-policy.html
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Special Selection Applicants: Apply by 05/28/21. Eligible Special Selection clients should contact their Disability Counselor for assistance.
As a key element of UCSD's overall program of protections for human research subjects, the Office of IRB Administration (OIA) is responsible for the implementation, management and oversight of the review of human subjects research and stem cell research conducted by UCSD investigators. The OIA supports seven research review committees: six federally mandated Institutional Review Boards (IRBs- 5 biomedical, 1 social & behavioral) and a Stem Cell Research Oversight Committee (SCRO). The OIA also manages relationships with a range of external IRBs.
Serves as subject matter/technical expert and as a resource for the review of pediatric research, including clinical trials, conducted by UCSD and Rady Children's Hospital San Diego (RCHSD). Maintains up-to-date knowledge of state and federal regulations regarding human subjects protections, especially for research involving children, and of related UC, UCSD and RCHSD policies and procedures. Interprets, applies and communicates those requirements in support of the UCSD and RCHSD research communities, which including IRB members and OIA colleagues, researchers and their teams, and other central offices and institutional leadership. Support UCSD IRB serving as single IRB for multi-site projects led by UCSD/RCHSD researchers.
Nine (9) years of related experience, education/training, OR a Bachelor’s degree in related area plus five (5) years of related experience/training.
Advanced knowledge and ability to apply all relevant Federal, state, and university regulations policies, and federal guidance documents. These regulations include but are not limited to 45 Code of Federal Regulations 46, 21 CFR 56, Health Insurance Portability and Accountability Act. In particular, this position requires frequent and careful application of regulatory requirements surrounding inclusion of children in research.
Advanced knowledge and ability to apply all relevant Federal, state, and university regulations policies, and federal guidance documents. Advanced, comprehensive knowledge of federal, state, and local regulations and policies governing human subject research including: the HHS-OHRP regulations, Food and Drug Administration (FDA) regulations for the use of investigational drugs, biologics and devices, Required California law on human experimentation, and university policy regarding human subjects research.
Thorough knowledge of quantitative and qualitative research design, scientific research concepts and terminology.
Strong proficiency in public speaking, and writing.
Highly effective written, oral communication skills and interpersonal skills to work closely and effectively with faculty members conducting research, committee members, committee chairpersons, senior academic and administrative officers, and federal regulatory and funding agencies. Ability to interact with high level administrators of other universities, academic and community health centers, research sponsors, and federal and state regulatory agencies.
Proven ability to independently and accurately represent UCSD policies regarding human subjects research in interactions with high level administrators of other universities, academic and community health centers, research sponsors, and federal and state regulatory agencies.
- Certified IRB Professional or Certified IRB Manager.
- Advanced knowledge of single IRB, reliance, and problem-solving skills to implement new approaches to reviewing human research.
- Employment is subject to a criminal background check.
- Ability to attend meetings after usual working hours. Most IRB meetings run from approximately 5pm - 7pm on Thursday evenings, and the analyst routinely supports one meeting per month.
Job offer is contingent on successful engagement in the UC COVID-19 Vaccination program (fully vaccinated with documented proof or approved exception/deferral).
UC San Diego Health is the only academic health system in the San Diego region, providing leading-edge care in patient care, biomedical research, education, and community service. Our facilities include two university hospitals, a National Cancer Institute-designated Comprehensive Cancer Center, Shiley Eye Institute, Sulpizio Cardiovascular Center, and several outpatient clinics. UC San Diego Medical Center in Hillcrest is a designated Level I Trauma Center and has the only Burn Center in the county. We invite you to join our dynamic team!
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