University of Iowa Hospitals and Clinics
The University of Iowa Office of the Vice President for Research and Economic Development seeks a self-motivated and highly skilled professional to serve as a Senior Application Analyst in the Human Subjects Office. This position will design, plan, promote, and conduct activities of substantial complexity and impact for the human subject protection programs and services. It will develop and coordinate procedures and programs to enhance investigator compliance with the Institutional Review Board (IRB) application process. This position will attend IRB meetings to document the discussion of regulatory determinations and any further actions needed for IRB approval.
Serve as liaison between IRB chairs, HSO staff, and UI investigators in enhancing the efficiency and effectiveness of the IRB application and review process.
Conduct intensive, content-based review of research project application materials.
Assist researchers and project coordinators in preparing and submitting complete IRB application materials and appropriately written Informed Consent Documents.
Meet/communicate with investigators and coordinators to suggest additions or revisions that are necessary prior to IRB review.
Consult with investigators regarding proposed new research projects that are in the planning stage and provide advice on issues related to IRB review and approval.
Coordinate and work closely with HSO professional staff and IRB chairs regarding scheduling of IRB applications that have had intensive preliminary review.
Attend IRB meetings and document the discussions and determinations of the IRB for protocols reviewed at full board IRB meetings.
Compile relevant information from FDA and OHRP letters for review at Chairs meetings.
Assist in compiling reporting letters to various external regulatory agencies and internal institutional administration.
Develop, implement, and evaluate educational programs and materials aimed at enhancing the efficiency of the IRB application process.
Assist in planning and presenting educational workshops and seminars on various topics as assigned.
Assist in providing written content for the monthly HSOIRB newsletter, IRB Connection.
Participate in IRB Office Hours.
Prepare, maintain and update records and summary reports.
Serve as technical expert on the use of the HawkIRB data management system and the IRB application process.
Occasional functional supervision over student employees.
Note to applicant:
Five professional references will be requested and required at a later step in the recruitment process.
Experience (typically 3-5 years) conducting intensive research compliance or regulatory review of research involving biomedical research design randomized clinical trials, andor investigational device trials.
Evidence of strong writing, speaking, and organizational skills.
Demonstrated ability to interact with clients on a broad range of sensitive topics.
Experience with Microsoft Office software and the World Wide Web.
Experience conducting and/or monitoring research involving human participants.
Experience in preparing and submitting IRB application materials and Informed Consent Documents.
Working knowledge of biomedical research design, conduct and regulations, including experience with randomized clinical trials.
$40,805.00 to Commensurate