Senior IRB Analyst
Permanent Staff (SHRA)Is this an internal only recruitment?:
Soc/Clin Research Specialist - AdvancedWorking Title:
Senior IRB AnalystPosition Number:
P012377Budgeted Hiring Range:
$54,652 - $68,000Pay Band Information:
To learn more about the pay band for this branch and role, please see the Career Banding rates spreadsheet.Salary Grade Equivalent:
Full-Time PermanentHours per week:
Monday – Friday, 8:00 A.M. to 5:00 P.M.Department Name and Number:
Ofc of Human Research Ethics-621300Date First Posted:
Chapel Hill, NCPosition Posting Category:
Research ProfessionalsDepartment Description:
The OFFICE OF HUMAN RESEARCH ETHICS (OHRE) administers supports and oversees the work of the Institutional Review Boards (IRBs) at UNC-Chapel Hill, and all related activities. Any research projects involving human subjects proposed by the faculty, staff and students at UNC-Chapel Hill must be reviewed and approved by an IRB before research may begin, and before related grants may be funded. These IRBs are federally mandated review committees, operating under regulations promulgated by the Office for Human Research Protections (OHRP) of the U.S. Department of Health and Human Services (DHHS) and the U.S. Food and Drug Administration (FDA). The IRBs and OHRE are critical components of a program that serves to protect the rights and welfare of human research subjects. All components of this program, coordinated through the OHRE, must work together to ensure institutional compliance with ethical principles and regulatory requirements.
This system evolved in a decentralized manner at UNC-Chapel Hill, with eight IRBs operating out of five separate, school-based offices. This resulted in inefficiencies and variability that compromised the University’s ability to fulfill these important obligations. In order to remedy this situation and position UNC-Chapel Hill for the future, the OHRE was established in 2003, reporting to the Vice Chancellor for Research. In 2006 the OHRE received full accreditation from the Association for the Accreditation of Human Research Protection Programs and continues to maintain that accreditation.
The OHRE now employs 20 SHRA and EHRA staff reporting to a single Director. Working with 6 IRB Chairs and over 80 IRB members, it is their shared responsibility to educate the research community regarding federal regulations and IRB procedures, to process all submissions, to maintain accurate records of new and previously approved protocols, and to comply with all applicable regulations.Equal Opportunity Employer:
The University of North Carolina at Chapel Hill is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to age, color, disability, gender, gender expression, gender identity, genetic information, race, national origin, religion, sex, sexual orientation, or status as a protected veteran.Position Description:
This position serves as a regulatory compliance analyst, educator and manager who exercises operational responsibility on a daily basis for the Office of Human Research Ethics (OHRE) and IRBs charged with protecting the rights and welfare of human research participants. Responsible, either directly or through managing others, for ensuring that IRB protocols satisfy federal regulations, guidelines and institutional requirements.
The Senior Analyst makes professional level decisions that are binding for the University. Misinformation, inaccuracy, or misinterpretation of the federal regulations involving human subject research could jeopardize the University’s federal certification to conduct human research studies and receive federal funds. Errors could delay or prevent the awarding of contracts and grants. The University currently receives about $800 million in external funding; a majority of this funding is dependent on oversight by this office. The Federal Wide Assurance approved by the Dept. of Health and Human Services, which allows the University to receive federal funds, could be suspended if an audit uncovered irregularities in human subject protection. Deficiencies in this area have led to very public suspensions of research at peer universities, which have been very costly and damaging for these institutions. As serious as this would be, an even greater harm could result if errors or lack of proper oversight by this office resulted in injuries to human subjects.Minimum Education and Experience Requirements:
Bachelor’s degree in a discipline related to the field assigned and one year of related training or experience; or equivalent combination of training and experience. All degrees must be received from appropriately accredited institutions.Essential Skills, Knowledge and Abilities:
- Certified Institutional Review Board (IRB) Professional (CIP) status or achievement of this certification within one year of hire is required.
- Knowledge of federal regulations for the protection of human subjects in research.
- Ability to interpret, apply and communicate federal and institutional guidelines, regulations, statutes, and policies.
- Ability to work collaboratively and to communicate effectively with a variety of constituencies including faculty, administrators, institutional compliance staff, federal agency professionals and regulators, and institutional support staff.
- Demonstrated ability to manage multiple priorities and activities while maintaining attention to detail.
- Must possess leadership and management skills as well as the ability to know when to utilize them. Basic office computer and software skills.
A working knowledge of Microsoft Office suite is desirable. Knowledge of qualitative and quantitative research methodologies and scientific terminology is preferred.Position/Schedule Requirements:
Evening work occasionally, Weekend work occasionallyStimulus/ARRA Funded: