IRB Generalist - Research Administration

Department:

RI Human Research Protection Program (HRPP)

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HRPP Administration

Position Title:

IRB Generalist - Research Administration

Job Family Group:

Professional Staff

Job Description Summary:

The Institutional Review Board (IRB) Generalist – administrative liaison is trained to evaluate submissions to the KUMC IRB to determine applicable regulatory and institutional requirements for approval.
The IRB Generalist position plays an integral role in the day-to-day functions of the IRB office. Duties include preliminary evaluation of research studies for completeness and identifying other federal and institutional requirements for the project. The position will be trained to support IRB meetings by preparing agendas, advising members on regulatory matters, writing meeting minutes, and providing post-meeting communications. The position will also process follow-on activities related to research studies.

Job Description:

Key Roles and Responsibilities:

• Perform review of submissions of research studies to determine applicable institutional and regulatory requirements.

• Provide instruction and advice to researchers on regulations and research studies.

• Attend IRB meetings, inform members about institutional and regulatory requirements, and write meeting minutes. 

• Communicate committee review results 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. 

• Process the electronic submission of all IRB submissions, including, but not limited to, amendments, problem reports, continuing reviews, and study closures.

• Assist research study teams in the use of the electronic submission system.

• Keep abreast of changes in regulations and communicate changes to IRB members.

• Other duties as assigned.

Work Environment

Work is normally performed in a typical interior work environment which does not usually subject the employee to any unpleasant elements.

Required Qualifications:

Education:

• A bachelor’s degree; or an equivalent combination of education and relevant work experience on a year for year basis.

Experience:

• Previous experience exercising independent judgment in a highly regulated environment which demands consistent accuracy and attention to detail.

• Previous customer-service experience in a high-volume administrative office.

Preferred Qualifications:

Education/Certification:

• Designation as a Certified IRB Professional.

Experience:

• Four years relevant work experience in an IRB environment, supporting an IRB, or within a research setting involving research participants.

• Experience and working knowledge of the State of Kansas and University policies, programs and procedures.

Skills:

• Demonstrated reliability and a proven work ethic.

• High degree of skill and aptitude for working in an electronic environment.

• Strong communication skills and the ability to interact professionally with faculty investigators, IRB members, and other compliance professionals.

This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. It is only a summary of the typical functions of the job, not an exhaustive list of all possible job responsibilities, tasks, duties, and assignments. Furthermore, job duties, responsibilities and activities may change at any time with or without notice

Required Documents:

• Resume/CV

• Cover Letter

Comprehensive Benefits Package:

Coverage begins on day one for health, dental, and vision insurance and includes health expense accounts with generous employer contributions if the employee participates in a qualifying health plan. Employer-paid life insurance, long-term disability insurance, and various additional voluntary insurance plans are available. Paid time off, including vacation and sick, begins accruing upon hire, plus ten paid holidays. One paid discretionary day is available after six months of employment, and paid time off for bereavement, jury duty, military service, and parental leave is available after 12 months of employment. A retirement program with a generous employer contribution and additional voluntary retirement programs (457 or 403b) are a