Senior IRB Administrator

Creighton University in Omaha, NE is seeking to hire a Senior Institutional Review Board Administrator (Administrator III) in the Office of Research Compliance.

Reporting to the IRB (Institutional Review Board) Director, the Senior IRB Administrator is primarily responsible for ensuring research proposals submitted for IRB review are accurately and efficiently assessed for completeness, level of review (Exempt, Expedited, Full Board), and compliance with all applicable regulations and guidance pertaining to the protection of human subjects in research. The Senior Administrator also provides regulatory support to the Creighton University Biomedical and Social Behavioral Review Boards (Chairs and Board members), as well as to the broader university research community. This position will work Monday to Friday, normal business hours. Main  location – Omaha, NE. Depending on qualifications, this position may be eligible for remote work.

Responsibilities

Human Subjects Research Oversight (65%, High Importance)

• Serving as a member of the IRB, reviews IRB submissions including new protocols, modifications, reportable new information, and requests for continuing review.
• Reviewing applications for non-human subjects research and quality improvement determinations.
• Reviewing exempt and expedited research and other submissions permissible for review via the expedited approval pathway.
• Efficiently and effectively executing a high volume of complex reviews, applying knowledge of all applicable laws, ethical principles, university and accreditation standards to each review.
• Adhering to expected turnaround times for IRB review.
• Providing guidance and mentorship to IRB Administrators I and/or II.

Investigator Support and University Outreach (15%, High Importance)

• Working collaboratively with student and faculty researchers on protocol and consent form development, study design, and required revisions to IRB submissions.
• Providing regulatory guidance and support to university faculty, staff, and investigators. Conduct regulatory and ethical consultations for investigators, as needed.
• Providing ongoing human subjects research education for investigators, board members, and the university research community. Assisting the IRB Director with monthly training on IRB topics, educational outreach with study coordinators, and Human Subjects Research training and workshops on a University-wide,as needed basis.
• Assisting investigators with the electronic submission database. Participating in the development of University-wide training for new users. 

Support to the IRB (10%, High Importance)

• Providing administrative management and guidance to the University’s Institutional Review Boards, partnering with the IRB Administrator to prepare and facilitate monthly board meetings.
• Serving as primary regulatory reviewer for Full Board agenda items and supporting Board members in leading primary scientific review.
• Providing regulatory guidance and support to IRB Chairs and board members.

HRPP Quality Assurance and Improvement (5%, Moderate Importance)

• Working collaboratively with IRB leadership and members of the Research Compliance Office to encourage and support the compliant review and conduct of human subjects research on the Creighton University Campuses and conducted by Creighton faculty and students within the University and CHI Health facilities.
• Making suggestions regarding process improvements to increase efficiency of review.
• Maintaining and upholding AAHRRP Accreditation and other best practices by remaining compliant with AAHRPP organizational standards; ensuring that ethical standards are constantly being met by following written policies and procedures for reviewing the scientific or scholarly validity of proposed research studies
• Assisting IRB leadership with the review, development, and implementation of HRPP policies and procedures.
• Completing other research and compliance duties or special projects as assigned.
• Continuing Education (5%, Moderate Importance)
• Staying current with regulatory changes in human research protections regulations and policies, providing guidance to the university research community regarding the interpretation and application of these regulations and policies.

Qualifications

• 4 + years of IRB or HRPP experience (experience working in a research environment in an Academic Medical Center, higher education, or related field may be counted as equivalent to IRB or HRPP experience depending on prior job functions and responsibilities);
• Bachelor’s Degree
• CIP certification (or CIP eligibility)
• Demonstrated knowledge and understanding of federal regulations governing IRBs, including 21 CFR 50 and 56, and 45 CFR 46;
• Knowledge or experience in ethics and/or health, law, healthcare administration, research process and health care settings including regulatory aspects that involve human research subjects and Institutional Review Boards;
• Proficiency in Microsoft Office Suite to include Word, Excel; PowerPoint and Outlook.

Knowledge, Skills, Abilities

• Ability to function effectively and collaboratively as a team member while exercising independent and sound judgment;
• Critical thinking skills and attention to detail;
• Ability to make accurate and appropriate independent judgments, including when to escalate issues, and able to accept direct supervision;
• Self-Motivated to function independently within a deadline-driven environment;
• Strong organization and time management skills, able to prioritize work with multiple and conflicting demands in a deadline-oriented environment;
• Strong interpersonal and communication (verbal and written) skills and the ability to work effectively with a wide range of constituencies in a diverse community; building and maintaining respectful, collaborative relationships with all stakeholders;
• Ability to coordinate and organize meetings;
• Ability to lead and train staff and/or students;
• Knowledge or experience in ethics and/or health, law, healthcare administration, research process and health care settings;
• Knowledge in research process including regulatory aspects that involve human research subjects and Institutional Review Boards.
• Ability to work beyond normal business hours at times depending upon departmental needs