Senior IRB Administrator-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 and research integrity. The 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.

Accepting applications.  Final candidate selected may be hired to work on the Omaha, NE Creighton campus or Phoenix, AZ Creighton campus.  
Responsibilities will include: 
•    Working collaboratively with IRB leadership and members of the Research Compliance Office to encourage and support the compliant conduct of human subjects research on the Creighton University Campuses and conducted by Creighton faculty and students within the University and CHI Health facilities. 
•    Conducting regulatory and administrative review of IRB submissions (new protocols, modifications, reportable new information, and continuing review).
•    Assessing submissions by level of review and routing appropriately for review or revision. 
•    Reviewing and/or approving applications for non-human subjects research, exempt, and quality improvement determinations.
•    Reviewing and/or approving new exempt research and other submissions capable of review via the expedited pathway (NOTE: Per CU IRB policy, only CIP certified candidates may review and approve expedited research and other submissions eligible for expedited review. A candidate who is CIP eligible at the time of hire will be permitted to review and approve expedited submissions upon successfully passing the CIP exam). 
•    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 turnaround times for IRB submissions and making suggestions regarding process improvements to increase efficiency of review. 
•    Providing administrative management and guidance to the University’s Institutional Review Boards, partnering with the IRB Specialist to prepare and facilitate bi-weekly board meetings., 
•    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 IRB Chairs and board members, university faculty and staff, and investigators. Conduct regulatory and ethical consults for investigators, as needed.
•    Assisting investigators with the Office of Human Subjects research electronic database. Participating in the development of University-wide training for new users. 
•    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.
•    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
•    Help in overseeing the quality assurance monitoring of the human Research protection Plan (HRPP), including research protocols and investigation of matters of non-compliance. Assisting with the implementation of corrective action plans, as needed, in accordance with Creighton IRB policies and procedures and conditions imposed following external audits conducted by agencies charged with the oversight of human subject protection and welfare
•    Providing ongoing human subjects research education for investigators, board members, and the university research community by assisting the IRB Director with monthly training on IRB topics, educational outreach with study coordinators (CURE Meetings), and Human Subjects Research training and workshops on a University-wide as needed basis.
•    Working with IRB leadership to review, develop, and implement HRPP policies and procedures. 
•    Providing mentorship to the IRB Specialist. 
•    Completing other research and compliance duties as assigned.
This position will work Monday to Friday, normal business hours. 

Qualifications:
Minimum of two-years of IRB or HRPP experience;
Bachelor’s Degree with CIP certification (or CIP eligibility); 
4-6 years' experience working in a research environment in an Academic Medical Center, higher education, or related field is preferred;
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.

Required Licenses/Certifications:
CIP certification or CIP eligibility 

Physical Requirements:
Seeing: 75 – 100%
Hearing: 75-100%
Standing/Climbing/Mobility: 25-75%
Lifting/Pulling/Pushing: 0-24% (pound: up to 10 lbs.)
Fingering/Grasping/Feeling: 75-100%
Travel: Yes (less than 5%)
Exposure to Blood Borne pathogens: No

AAP/EEO Statement:
Creighton University is committed to providing a safe and non-discriminatory educational and employment environment. The University admits qualified students, hires qualified employees and accepts patients for treatment without regard to race, color, religion, sex, marital status, national origin, age, disability, citizenship, sexual orientation, gender identity, gender expression, veteran status, or other status protected by law. Its education and employment policies, scholarship and loan programs, and other programs and activities, are administered without unlawful discrimination.

Disclosure Statement:
This description describes the general nature of work to be performed and does not include an exhaustive list of all duties, skills, or abilities required. Regular, reliable attendance is an essential function and all employees are required to follow any other job-related instructions and to perform any other job-related duties as requested by their supervisor. Employees may also be required to work in excess of normal working hours as workloads and seasonal activities necessitate. A complete description is available in the Human Resource office located at 3006 Webster Street Omaha, NE. Creighton University reserves the right to modify duties, responsibilities and activities at any time with or without notice.