Senior Institutional Review Board Administrator-Research & Compliance

Updated: 24 days ago
Location: Omaha, NEBRASKA

This IRB (Institutional Review Board) Administrator administers and implements daily operating procedures & policies associated with the review of all IRB submissions in accordance with federal, state and local regulatory requirements/guidelines related to the protection of human subjects and research integrity.

Responsibilities will include: 

  • Provide administrative management and guidance to the operational aspects of the University’s Institutional Review Board (two separate panels) responsible for preparing, attending and facilitating bi-weekly board meetings, tracking quorum as well as providing ongoing support and oversight to all research conducted within the University and CHI Health facilities.
  • Review and/or approve all submissions to determine appropriate level of review (exempt, expedited and full board), resolving differences between federal and state laws as well as the University’s regulations and mission.
  • Assist investigators with the Office of Human Subjects research electronic database; especially responsible for revision of IRB applications, addendums and templates.  Help develop University-wide training for new users as well as auditing of protocol submissions for accuracy
  • Stay current with regulatory changes in human research protections guidelines and policies, providing guidance regarding the interpretation of the regulations
  • Maintain and uphold the AAHRRP Accreditation 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 HRPP, including research protocols and investigation of matters of non-compliance. Assist in the implementation of corrective action, as needed, in accordance with Creighton IRB policies and procedures as well as external audits conducted by agencies charged with the oversight of human subject protection and welfare
  • Assist in providing ongoing education to research investigators including monthly topics and educational outreach for study coordinators (CURE Meetings) and IRB Chairs and members as well as help facilitate Human Subjects Research training and workshops on a University wide as needed basis.
  • Other research and compliance duties as assigned.

This position will work Monday to Friday, normal business hours. 
 


Qualifications:
Bachelor’s Degree with CIP certification preferred; 
5+ years’ experience working in a research environment in an Academic Medical Center, higher education, or related field is also preferred;
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:
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 function effectively as a team member, while exercising independent and critical judgment;
Ability to coordinate and organize meetings;
Strong interpersonal and communication (verbal and written) skills and the ability to work effectively with a wide range of constituencies in a diverse community;
Ability to lead and train staff and/or students;
Attentiveness to detail and analyze data and generate reports;
Ability to prioritize work with multiple and conflicting demands in a deadline-oriented environment;
Ability to work beyond normal business hours at times depending upon departmental needs
Required Licenses/Certifications:
CIP certification preferred
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.


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