The IRB Administrator I will serve as the point of contact (POC) for central IRB review of human subject research, as well as provide oversight of human subject research registered on ClinicalTrials.gov. This individual will work closely with the assigned IRB Administrator III to assure compliance with all UNMC, federal, and state requirements governing human subject research. This individual will attend IRB meetings as a non-member.
Central IRB Point of Contact:
1) Serve as a liaison between investigators, coordinators, sites, other IRBs, and other IRB administrators regarding CIRB process 2) Provide prompt review of all Reliance Agreement requests and any supporting documents in consultation with the Institutional Official, IRB Executive Chair, assigned IRB Administrator III, other Organizational officials, legal counsel, and other IRB staff (as necessary) 3) Secure approval of all Reliance Agreements from the Institutional Official 4) Communicate UNMC’s decision to serve as the reviewing IRB, cede review to the proposed reviewing IRB, or retain local IRB review of research 5) Maintains a tracking mechanism for all human subject research utilizing the CIRB process
Clinical Trials Gov Administration:
1. Possess a working knowledge of the federal requirements regarding ClinicalTrials.gov registration 2. Monitor ClinicalTrials.gov records to ensure continuing accuracy with the IRB approved protocol 3. Ensure all ClinicalTrials.gov records are routinely updated in compliance with reporting requirements 4. Ensure all ClinicalTrials.gov records provide trial results in compliance with report requirements 5. Ensure appropriate transfer or closure of ClinicalTrials.gov records when an investigator joins or leaves UNMC 6. Notify the IRB Executive Chair and Institutional Official of noncompliance 7. Provide UNMC officials with standard compliance reports 8. Create and maintain a tracking system
Copy/Paste the following URL for full description and list of duties: https://unmc.peopleadmin.com/position_descriptions/22493
Bachelor's degree Healthcare, scientific, or business field
2 years related experience with the regulatory requirements associated with the conduct of human subject research or one year of direct IRB Administration experience
1) Ability to write standard formal letters 2) Possess necessary knowledge of IRB processes and federal regulations to effectively participate in resolution of problems 3) Take an active, participative role in the daily operations of the ORA 4) Able to communicate clearly with the entire research community 5) Able to problem solve as well as work calmly and professionally with individuals at varying levels of the Organization and other institutions 6) Be a self-starter with an attention to detail
A vital enterprise in the nation’s heartland, the University of Nebraska Medical Center has its eye on improving the future of health care in Nebraska and beyond. As Nebraska’s only public academic health sciences center, UNMC is committed to the education of a 21st century health care work force, to finding cures and treatments for devastating diseases, to providing the best care for patients, a...nd to serving our state and its communities through award-winning outreach. UNMC also is committed to embracing the richness of diversity, and is a major economic engine for the state of Nebraska.Led by Chancellor Jeffrey P. Gold, M.D., UNMC has six colleges and two institutes, serving about 3,700 students in more than two dozen programs. Our primary care program was recently ranked fourth in the nation by U.S. News & World Report, and our physician assistant program was ranked ninth. The university’s physical therapy, pharmacy and public health programs also are ranked among the top in the country. Major Units: College of Medicine, College of Nursing, College of Pharmacy, College of Dentistry, College of Public Health, Graduate College, College of Allied Health Professions, Eppley Institute for Research in Cancer and Allied Diseases, Fred & Pamela Buffett Cancer Center, Munroe-Meyer Institute, Stanley M. Truhlsen Eye Institute.