IRB Generalist

Department:
RI Human Research Protection Program (HRPP)

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HRPP Administration
Position Title:
IRB Generalist
Job Family Group:
Professional Staff
Job Description Summary:
The IRB generalist plays an integral role in the day-to-day functions of the IRB office. This generalist is a highly administrative position that will support the operations of other IRB staff. Duties include preliminary evaluation of research projects from initial submission to final approval; prescreening electronic submissions to ensure completeness and readiness for review by the KUMC Institutional Review Board (IRB); identifying other federal and institutional requirements for the project. The IRB Generalist will be trained to support IRB meetings by preparing agendas, advising members on regulatory status, writing meeting minutes, and providing post-meeting communications. The position will also process follow-on activities that occur during the life of the study.
Job Description:

Required Qualifications:

• A bachelor’s degree OR an equivalent combination of relevantpost-secondary education and work experience that equals at least 4 years will be considered.
• Demonstrated ability to exercise independent judgment and work successfully in a highly regulated environment which demands consistent accuracy and attention to detail
• Strong oral and written communications skills and the ability to interact professionally with faculty investigators, IRB members and other compliance professionals
• Demonstrated reliability and a proven work ethic
• High degree of skill and aptitude for working in an electronic environment
• Ability to maintain a customer-service orientation in a high-volume office

• Applicants must submit a cover letter addressing exactly how experience and qualifications meet the requirements of this job

Preferred Qualifications:

• Four years relevant work experience in an IRB environment or within a research setting involving human subjects.
• Working knowledge of the State of Kansas and University policies, programs and procedures
• Customer service experience beneficial
• Prior experience supporting an IRB
• Designation as a Certified IRB Professional

Job Duties Outlined:

• Perform pre-screen/review of electronic submissions of research proposals to determine the applicable institutional and regulatory requirements. Provide instruction and advice to researchers on regulations and preparation of applications.
• After completion of training, support IRB meetings by preparing agendas; prior to the meeting, consult with the IRB Chair or Co-Chair to identify study-specific topics for the board’s consideration. Overnight travel for training may be required.
• Attend IRB meetings, inform members about institutional and regulatory requirements, and write meeting minutes.
• Communicate clear and concisereview results in writing to the study team and field questions regarding the IRB’s conditions for study approval.
• For research not requiring review by the convened IRB, determine readiness for non-committee review.
• Evaluate and make regulatory determinations for submissions, i.e., determining whether a submission constitutes human research, whether human research is exempt and under which category(ies), whether human research can be reviewed by the expedited procedure and under which category(ies), whether human research must be reviewed by the convened IRB.
• Provide technical support and guidance on institutional and regulatory requirements and/or matters; write highly detailed meeting minutes to outline the issues analyzed by the committee and accurately documents the final determinations of the IRB.
• Serve as a voting member of the convened IRB, reviewing and providing input on full committee submissions.
• Process the electronic submission of other activities daily, including, but not limited to, amendments, problem reports, continuation reviews and closure requests for research overseen by the KUMC IRB and by external IRBs
• Require modifications to submissions in order for the criteria for approval to be met.
• Assist colleagues who are training investigators in the use of the electronic submission system.
• Keep abreast of changes in regulations and communicate changes to IRB members.
• Other duties as assigned
• Initial salary will be $57,000

Required Documents:

• Resume/CV
• Cover Letter

Employee Type:
Regular
Time Type:
Full time
Pay Rate Type:
Salary
Pay Grade:
A10
Pay Range:

Minimum

46680

Midpoint

58090

Maximum

70020

Department:
RI Human Research Protection Program (HRPP)

-----

HRPP Administration
Position Title:
IRB Generalist
Job Family Group:
Professional Staff
Job Description Summary:
The IRB generalist plays an integral role in the day-to-day functions of the IRB office. This generalist is a highly administrative position that will support the operations of other IRB staff. Duties include preliminary evaluation of research projects from initial submission to final approval; prescreening electronic submissions to ensure completeness and readiness for review by the KUMC Institutional Review Board (IRB); identifying other federal and institutional requirements for the project. The IRB Generalist will be trained to support IRB meetings by preparing agendas, advising members on regulatory status, writing meeting minutes, and providing post-meeting communications. The position will also process follow-on activities that occur during the life of the study.
Job Description:

Required Qualifications:

• A bachelor’s degree OR an equivalent combination of relevantpost-secondary education and work experience that equals at least 4 years will be considered.
• Demonstrated ability to exercise independent judgment and work successfully in a highly regulated environment which demands consistent accuracy and attention to detail
• Strong oral and written communications skills and the ability to interact professionally with faculty investigators, IRB members and other compliance professionals
• Demonstrated reliability and a proven work ethic
• High degree of skill and aptitude for working in an electronic environment
• Ability to maintain a customer-service orientation in a high-volume office

• Applicants must submit a cover letter addressing exactly how experience and qualifications meet the requirements of this job

Preferred Qualifications:

• Four years relevant work experience in an IRB environment or within a research setting involving human subjects.
• Working knowledge of the State of Kansas and University policies, programs and procedures
• Customer service experience beneficial
• Prior experience supporting an IRB
• Designation as a Certified IRB Professional

Job Duties Outlined:

• Perform pre-screen/review of electronic submissions of research proposals to determine the applicable institutional and regulatory requirements. Provide instruction and advice to researchers on regulations and preparation of applications.
• After completion of training, support IRB meetings by preparing agendas; prior to the meeting, consult with the IRB Chair or Co-Chair to identify study-specific topics for the board’s consideration. Overnight travel for training may be required.
• Attend IRB meetings, inform members about institutional and regulatory requirements, and write meeting minutes.
• Communicate clear and concisereview results in writing to the study team and field questions regarding the IRB’s conditions for study approval.
• For research not requiring review by the convened IRB, determine readiness for non-committee review.
• Evaluate and make regulatory determinations for submissions, i.e., determining whether a submission constitutes human research, whether human research is exempt and under which category(ies), whether human research can be reviewed by the expedited procedure and under which category(ies), whether human research must be reviewed by the convened IRB.
• Provide technical support and guidance on institutional and regulatory requirements and/or matters; write highly detailed meeting minutes to outline the issues analyzed by the committee and accurately documents the final determinations of the IRB.
• Serve as a voting member of the convened IRB, reviewing and providing input on full committee submissions.
• Process the electronic submission of other activities daily, including, but not limited to, amendments, problem reports, continuation reviews and closure requests for research overseen by the KUMC IRB and by external IRBs
• Require modifications to submissions in order for the criteria for approval to be met.
• Assist colleagues who are training investigators in the use of the electronic submission system.
• Keep abreast of changes in regulations and communicate changes to IRB members.
• Other duties as assigned
• Initial salary will be $57,000

Required Documents:

• Resume/CV
• Cover Letter

Employee Type:
Regular
Time Type:
Full time
Pay Rate Type:
Salary
Pay Grade:
A10
Pay Range:

Minimum

46680

Midpoint

58090

Maximum

70020