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Type of Position: Regular Percent Time: 100% Location: Iowa City Driver’s License Required: No
IRB Application Analyst We are seeking a full-time IRB Application Analyst to join the staff of a thriving research compliance office in a BIG10 institution of higher education. We offer a challenging and exciting work environment in which one has the opportunity to grow and learn about academic and biomedical human subjects research.
This position will support the Office of the Vice President for Research, Human Subjects Office, and Institutional Review Board. The IRB Senior Application analyst will design, plan, promote, and conduct activities requiring substantial attention to detail and a high level of accuracy. This position will also develop and coordinate procedures and programs to enhance investigator compliance with the IRB application process. The IRB Senior Application Analyst will also attend IRB meetings to document the discussion of regulatory determinations and any further actions needed for IRB approval.
Principal Duties and Responsibilities may include, but are not limited to:
Manage and conduct intensive, content-based review of research project application materials, focusing on accuracy, completeness, and appropriate Informed Consent Document content and reading level, as well as compliance with federal and University policies and regulations.
Attend IRB meetings as needed and serve as a regulatory expert on relevant aspects of IRB review and approval. Document the discussions and determinations of the IRB for protocols reviewed at full board IRB meetings.
Serve as liaison between IRB chairs, HSO staff, and UI investigators in enhancing the efficiency and effectiveness of the IRB application and review process.
About the University of Iowa The University of Iowa is one of the top 200 best global universities and a premier public research universities with 31,730 students from 114 countries and all 50 states. Founded in 1847, it is the state's oldest institution of higher education and is located alongside the picturesque Iowa River in Iowa City.
The Office of the Vice President for Research is committed to forging new frontiers of discovery by providing resources and support to researchers and innovators at the University of Iowa, to promote a culture of creativity that enriches the campus, the state, and the world. In FY20, the University of Iowa received $535.5 million in federal and non-federal funding for research.
The Human Subjects Office (HSO) was established by the Vice President for Research to provide administrative support for the University of Iowa Institutional Review Boards. An Institutional Review Board is a group of individuals charged with reviewing proposed research involving human subjects to ensure the protection of those subjects and compliance with federal human subjects regulations. The University of Iowa has three such review boards, each consisting of faculty, staff, and representatives from the Iowa City community.
Regular salaried position located in Iowa City, Iowa
Fringe benefit package including paid vacation; sick leave; health, dental, life and disability insurance options; and generous employer contributions into retirement plans
Education or Equivalency Required A Bachelor’s degree in a field of science or related field, or an equivalent combination of education and experience is required.
Working knowledge (1-3 years) of biomedical research design, conduct and regulations, including experience with randomized clinical trials is required.
Experience in preparing and submitting or reviewing IRB application materials and Informed Consent Documents is required.
Knowledge of University/Higher Education and federal regulations regarding the protection of human subjects participating in research including; HIPAA, FDA drug, biologic and device regulations.
Evidence of strong organizational skills and attention to detail.
Demonstrate excellent written and verbal communication, interpersonal, and relationship management skills, including the ability to interact with clients on a broad range of sensitive topics is required.
Extensive experience with Microsoft Office software, the internet and cloud based systems.
Master's degree is desirable.
Reasonably related (3-4 years) program coordination, administrative, lead projects and/or supervisory experience is desirable.
Demonstrated knowledge (3-5 years) of biomedical research design, conduct and regulations, including experience with randomized clinical trials is desirable.
Experience in coordinating a research program of high complexity, involving multiple researchers/sites/projects, is desirable.
Public speaking experience is desirable.
Application Details and Instructions: Upload the following documents and mark them as a “Relevant File” to the submission:
These attachments should clearly address how the applicants meet the listed required and desired qualifications of this position. An applicant who fails to submit the required materials will be considered incomplete and therefore are ineligible for interview.
Posting Announcement Information Job openings are posted for a minimum of 14 calendar days. This job may be removed from posting and filled any time after the minimum posting period has ended.
Please note regarding references: Five professional references will be requested and required at a later step in the recruitment process.
Successful candidates will be subject to a criminal background check and verification of academic credentials.
Internal Number: 21001687
About University of Iowa
Visit http://www.uiowa.edu/ for information regarding the University of Iowa. Information on the Office of the Vice President for Research can be found at http://research.uiowa.edu/
For information about applying for P&S positions, please go to Professional and Scientific Position Application Procedures (https://jobs.uiowa.edu/pands/how_to_apply/ps_app_procedures.php)
The qualifications for the positions are listed in the job advertisement. Equivalent combinations of education and related work experience may be considered. To review P&S or SEIU pay schedules or for a complete classification description go to the University of Iowa Compensation and Classification web site. (http://hr.uiowa.edu/compensation-classification)
The University of Iowa is an equal opportunity/affirmative action employer. All qualified applicants are encouraged to apply and will receive consideration for employment free from discrimination on the basis of race, creed, color, national origin, age, sex, pregnancy, sexual orientation, gender identity, genetic information, religion, associational preference, status as a qualified individual with a disability, or status as a protected veteran. The Univers...ity also affirms its commitment to providing equal opportunities and equal access to University facilities. Women and Minorities are encouraged to apply for all employment vacancies. For additional information on nondiscrimination policies, contact the Coordinator of Title IX and Section 504, and the ADA in The Office of Equal Opportunity and Diversity, 319/335-0705 (voice) or 319/335-0697 (text), The University of Iowa, 202 Jessup Hall, Iowa City, Iowa, 52242-1316. (http://diversity.uiowa.edu/office/equal-opportunity-and-diversity)
Persons with disabilities may contact University Human Resources/Faculty and Staff Disability Services, (319) 335-2660 or firstname.lastname@example.org, to inquire or discuss accommodation needs.
Prospective employees may review the University Campus Security Policy and the latest annual crime statistics by contacting the Department of Public Safety at 319/335-5022. (http://police.uiowa.edu/)
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