This role reports to the Chair of the department. This role implements strategic plans to complete daily operations. Specifically, the Director-IRB Research & Compliance will be responsible for the following:
Provides senior level guidance to all operational aspects of the University's Institutional Review Board (two separate panels) including managing the two IRB administrators responsible for preparing, attending and facilitating board meetings, providing ongoing support and IRB oversight to all research conducted within the University and CHI Health facilities. Responsible for conducting annual evaluations of IRB Chairs and Board members.
This roll will oversee and/or approve all submissions to determine appropriate level of review (exempt, expedited and full board), resolving differences between federal and local laws as well as in accordance with the University’s mission.
Develop, analyze and implement Creighton University human research protection policies and procedures as federal regulations evolve. Monitor federal regulatory websites and other research-related resources to stay current with regulatory changes in human research protections guidelines and policies, providing guidance regarding the interpretation of the regulations.
Responsible for management of the Office of Human Subjects Research's electronic database; responsible for revision of IRB applications, addendums and templates. Develop University- wide training for new users as well as auditing of protocol submissions for accuracy.
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. Responsible for complex application processes, metrics of HRPP performance, strategic planning of site visits by accreditors that include preparation and education to University researchers. Maintain Creighton University's Federal Wide Assurance (FWA) , ensuring compliance with its terms, as well as Creighton policies and procedures, federal regulations, and state and local laws relative to the conduct of human research studies.
Oversee the quality assurance monitoring of the HRPP, including research protocols and investigation of matters of non-compliance. Ensure 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.
Provides ongoing education for incoming faculty and students. Develops and presents monthly topics and educational outreach for study coordinators (CURE Meetings) and IRB Chairs and members as well as facilitate Human Subjects Research training and workshops on a University wide as needed basis.
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.
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.
Ideal candidates will have a bachelor’s degree in a related field with a Master’s degree preferred and hold a ClP certification (preferred); 10 years progressive working IRB experience within a research environment in an Academic Medical Center, higher education, or related field. Ideal candidates will have a strong knowledge base and working experience in ethics and/or research process and health care settings as related to IRB aspects including regulatory requirements.
This position will work Monday to Friday; normal business hours; depending upon university research needs position may require evening, weekend, and holiday work.
Qualifications: Bachelor's Degree in a related field; CIP certification preferred; 10 years working experience in a research environment in an Academic Medical Center, higher education, or related field; 2+ supervisory years’ experience; Proficiency skills in MS Office Suite to include Word, Excel, PowerPoint and Outlook;
Knowledge, Skills, Abilities: Strong knowledge base and working experience in ethics and/or research process and health care settings as related to IRB aspects including regulatory requirements; Excellent written/verbal communication, interpersonal, and organizational skills; Strong collaborative/teamwork ability to motivate, and inspire staff at all levels of the organization; Demonstrated experience with strategic thinking and planning; Demonstrated ability to develop and implement complex plans coordinated with multiple constituencies. Ability to manage, supervise, and develop professional staff; Results oriented; Mission and Service oriented
Creighton University, located in Omaha, Nebraska, is a comprehensive Jesuit university composed of nine colleges and schools including Arts and Sciences, Business Administration, Professional Studies, Law, Medicine, Nursing, Pharmacy and Health Professions, Dentistry, and a Graduate School. Located in the heart of downtown Omaha Creighton University spans across 130 acres. Creighton University is accredited by the Higher Learning Commission. Creighton University is an EEO/AA Employer: M/F/Disabled/Vets.