Institutional Review Board (IRB) Administrator - 005215

Overview

Posting Details

Position Information

Position Number	005215
Position Title	Institutional Review Board (IRB) Administrator - 005215
Division	Research and Economic Development
Department	140460 - Research Compliance and Assurance
Minimum Qualifications	Bachelor’s degree in a related field from an accredited institution as approved and accepted by the University of South Alabama and five years of related professional experience. An equivalent combination of education and experience may be considered
Preferred Qualifications	Certified IRB Professional (CIB) is preferred and will substitute for one year of the required experience.
Job Description Summary	The University of South Alabama’s department of Research Compliance and Assurance is seeking to hire an Institutional Review Board (IRB) Administrator. Interested candidates should apply to be considered.

Essential Functions

These are the job duties required of the position.

Essential Functions	Attains and maintains comprehensive and up-to-date knowledge of human subject research protections and Institutional Review Board (IRB) regulations as contained in 45 CFR 21 CFR 50 & 52, and other applicable regulations. Serves as the subject matter expert by providing guidance and training to researchers, faculty, staff, students, and IRB members. Oversees the day-to-day administrative operations of the IRB submission, review, and approval process. Ensures compliance, high quality review, and efficiency in IRB operations. Manages all aspects of IRB committee meetings, including ensuring adequate meeting attendance to conduct meetings, reviewer assignments, staff support, technical support, agenda creation, meeting minutes, and supporting the IRB chair in managing the meeting. Manages the IRB reliance program, including tracking of reliance agreements and procedures for reliance through various organizations and mechanisms, including review and oversight of collaborative research with the University. Oversees the continued expansion and streamlining of the reliance processes. Analyzes and reviews applications for the IRB to ensure completeness and compliance with appropriate federal and state laws, institutional policies, and University IRB guidelines. Determines whether research projects are exempt from further review. Reviews and approves certain research projects on behalf of the IRB as a designated reviewer. Responsible for administrative review and management of all External IRB submission requests (commercial IRBs, NCI IRB, and other independent external IRBs). Corresponds with researchers, articulating required modifications to study documentation, including informed consent forms, in order to secure IRB approval, and requesting additional information needed before approval can be considered. Maintains active knowledge of regulations and ethical norms applicable to human subject’s research through professional development activities. Performs other duties as required and participate in special projects as assigned. Works cooperatively with other Research Compliance staff and coordinates efforts with the office, including providing coverage as needed. Prepares board documents for deliberation at IRB meetings, attends IRB meetings, prepares meeting minutes, and communicates IRB determinations and actions to researchers. Works with Research Quality and Improvement team to help develop tools, templates and guidance to support the research community. Works collaboratively in identifying, correcting and preventing potential problems. Collaborates with Executive Director and the Associate Director, Research Quality and Improvement to identify focus areas for monitoring, systems improvements, policy/procedure development/revision and education to ensure a high quality, compliant, and efficient human subject’s research program. Develops and participates in training and educational activities on human research protections that are presented to researchers and administrators. Serves as the subject matter expert by providing guidance and training to researchers, faculty, staff, students, and IRB members. Trains new IRB members and clinical research regulatory staff on how to use the electronic review system and facilitates onboarding. Works with Executive Director in the review and updates of new member orientation materials. Provides guidance to researchers and administrators on the use of the online electronic management systems used by the University to manage applications for review and automate correspondence. Works with Executive Director and team members in keeping website material up-to-date and in the development of educational resources. Conducts quality control functions in areas of operation to include review of files and meeting minutes for completeness, accuracy, and consistency. Assists the Executive Director with policy and guidance revision, procedural changes and other IRB programmatic issues. Assists Executive Director in the preparation of any announced federal regulatory inspections of the IRB. Develops and implements education sessions on topics related to human subject’s research protections to UIC researchers and IRB members. Anticipates future application submission for the Association for the Accreditation of Human Research Protection Program (AAHRPP) accreditation. Assist the Executive Director in maintaining full AAHRPP accreditation for the institutional human research protection program. Assists with draft AAHRPP accreditation renewal applications, annual reports, training materials for site visits, and responses to site visits. Regular and prompt attendance. Ability to work schedule as defined and additional hours as required. Related duties as required.

Essential Functions

Attains and maintains comprehensive and up-to-date knowledge of human subject research protections and Institutional Review Board (IRB) regulations as contained in 45 CFR 21 CFR 50 & 52, and other applicable regulations.
Serves as the subject matter expert by providing guidance and training to researchers, faculty, staff, students, and IRB members.
Oversees the day-to-day administrative operations of the IRB submission, review, and approval process.
Ensures compliance, high quality review, and efficiency in IRB operations.
Manages all aspects of IRB committee meetings, including ensuring adequate meeting attendance to conduct meetings, reviewer assignments, staff support, technical support, agenda creation, meeting minutes, and supporting the IRB chair in managing the meeting.
Manages the IRB reliance program, including tracking of reliance agreements and procedures for reliance through various organizations and mechanisms, including review and oversight of collaborative research with the University.
Oversees the continued expansion and streamlining of the reliance processes.
Analyzes and reviews applications for the IRB to ensure completeness and compliance with appropriate federal and state laws, institutional policies, and University IRB guidelines.
Determines whether research projects are exempt from further review.
Reviews and approves certain research projects on behalf of the IRB as a designated reviewer.
Responsible for administrative review and management of all External IRB submission requests (commercial IRBs, NCI IRB, and other independent external IRBs).
Corresponds with researchers, articulating required modifications to study documentation, including informed consent forms, in order to secure IRB approval, and requesting additional information needed before approval can be considered.
Maintains active knowledge of regulations and ethical norms applicable to human subject’s research through professional development activities.
Performs other duties as required and participate in special projects as assigned.
Works cooperatively with other Research Compliance staff and coordinates efforts with the office, including providing coverage as needed.
Prepares board documents for deliberation at IRB meetings, attends IRB meetings, prepares meeting minutes, and communicates IRB determinations and actions to researchers.
Works with Research Quality and Improvement team to help develop tools, templates and guidance to support the research community.
Works collaboratively in identifying, correcting and preventing potential problems.
Collaborates with Executive Director and the Associate Director, Research Quality and Improvement to identify focus areas for monitoring, systems improvements, policy/procedure development/revision and education to ensure a high quality, compliant, and efficient human subject’s research program.
Develops and participates in training and educational activities on human research protections that are presented to researchers and administrators.
Serves as the subject matter expert by providing guidance and training to researchers, faculty, staff, students, and IRB members.
Trains new IRB members and clinical research regulatory staff on how to use the electronic review system and facilitates onboarding.
Works with Executive Director in the review and updates of new member orientation materials.
Provides guidance to researchers and administrators on the use of the online electronic management systems used by the University to manage applications for review and automate correspondence.
Works with Executive Director and team members in keeping website material up-to-date and in the development of educational resources.
Conducts quality control functions in areas of operation to include review of files and meeting minutes for completeness, accuracy, and consistency.
Assists the Executive Director with policy and guidance revision, procedural changes and other IRB programmatic issues.
Assists Executive Director in the preparation of any announced federal regulatory inspections of the IRB.
Develops and implements education sessions on topics related to human subject’s research protections to UIC researchers and IRB members.
Anticipates future application submission for the Association for the Accreditation of Human Research Protection Program (AAHRPP) accreditation.
Assist the Executive Director in maintaining full AAHRPP accreditation for the institutional human research protection program.
Assists with draft AAHRPP accreditation renewal applications, annual reports, training materials for site visits, and responses to site visits.
Regular and prompt attendance.
Ability to work schedule as defined and additional hours as required.
Related duties as required.

Posting Information

Number of Vacancies	1
Position End Date (if temporary)
Job Open Date	11/06/2024
Job Close Date
Open Until Filled	Yes
Special Instructions to Applicants
Working Days	Monday - Friday
Working Hours	8:00 a.m. - 5:00 p.m.
Job Location	Main Campus
Full-time or Part-Time	Full Time
Regular or Temporary	Regular

Supplemental Questions

Required fields are indicated with an asterisk (*).

* Are you at least 18 years of age?
- Yes
- No
* Do you have a legal right to work in the United States?
- Yes
- No
* The University of South Alabama typically does not sponsor individuals for staff positions. Will you now or in the future require sponsorship for employment visa status?
- Yes
- No
* What is the highest level of education you have completed?
- Less than High School
- High School Diploma or equivalent
- Associates Degree
- Bachelors Degree (or will obtain within 6 months)
- Masters Degree (or will obtain within 6 months)
- Terminal Degree (or will obtain within 6 months)
* How many years of related experience do you have?
- Less than 1 year
- Between 1 - 3 years
- Between 3 - 5 years
- Between 5 - 7 years
- More than 7 years
* How did you hear about this position?
- USA website
- LinkedIn
- Zip Recruiter
- Indeed
- HigherEd Jobs
- Alabama Career Center / Alabama Works
- Facebook
- Word of mouth
- Other

Applicant Documents

Required DocumentsOptional Documents

Resume
Cover Letter

The University of South Alabama is an EO/AA employer and does not discriminate on the basis of race, color, national origin, sex, pregnancy, sexual orientation, gender identity, gender expression, religion, age, genetic information, disability, protected veteran status or any other applicable legally protected basis. If you feel you have been discriminated against, please notify the Equal Employment Opportunity Investigator or the Associate Vice President, Finance and Administration/CHRO.

EO/AA Employer – minorities/females/veterans/disabilities/sexual orientation/gender identity.

Annual Security and Fire Safety Report
The University of South Alabama publishes certain crime statistics for the most recent three-year period as required by the Jeanne Clery Act. The Annual Security and Fire Safety Report is required by federal law and contains policy statements and crime statistics for the school. The report, along with additional information, is available online at: http://www.southalabama.edu/departments/police/resources/fireandsafetyreport.pdf. You may also request a paper copy from the University Police office located at 290 Stadium Blvd, Beta Gamma Commons Building, Mobile, AL 36688.

Apply Here: https://www.click2apply.net/QyAeMxIJG8g14C81KsgVeX

PI254591387

Contact Information

Company: University of South Alabama
First Name: Brie
Last Name: Thomas
Address
Phone: 251-460-7897
Contact Email: bkthomas@southalabama.edu
Contact URL

Background Information

Education

4-Year Degree

Years of Experience

Industries

Categories

Work Authorization

Security Clearance

None

Target Job Information

Salary

Job Type

Full Time