"IRB Protocol Analyst II"

Job Summary

The IRB Protocol Analyst 2 provides oversight of regulated human research submissions requiring minimal supervision for submissions of moderate scope and complexity; coordinates Institutional Review Board (IRB, Board) member activities; utilizes general industry knowledge and professional experience in applying federal regulations, state laws, and human research protection program policies to ensure compliance with sponsor and university requirements; analyzes research submissions and applies independent judgement to provide guidance to principal investigators and research teams; documents complex regulatory findings, board deliberations and actions; coordinates activities with ancillary review committees, college support staff, Office of Sponsored Programs, and Office of Research Compliance; communicates with investigators and assists researchers to secure timely Board approvals; prepares inter-institutional agreements and regulatory documents for institutional official signature; continually monitors timelines to avoid delays and approval lapses; meets internal quality standards to ensure regulatory compliance; identifies customer service needs and proposes solutions; assists in business process improvement initiatives and the development of education programs; works with QI team to conduct training sessions for research teams and IRB members; operates within electronic submission system for communications management and document management; regularly attends webinars, local regulatory conferences, and ORRP sponsored workshops and events for continuing education and training; may serve as liaison or representative for ORRP events; monitors changes in regulations, Ohio State policies, and HRPP policies to remain current with compliance standards; participates in identifying process improvements; assists/mentors entry level protocol analysts; assists in electronic submission system testing and provides feedback for enhancements; participates in additional duties and projects within the operation as needed.

Required Qualifications

Bachelor's degree or equivalent combination of education and experience. 2 years of relevant work experience. Customer service experience; problem-solving experience. Ability to work in a regulatory and deadline driven environment. Ability to work almost exclusively on a computer using regulatory application software; proficient use of Microsoft Office Suite. Strong written communication skills. 1 year of experience working in human subjects research.

Desired Qualifications

2-4 years of relevant work experience. Knowledge and experience with research methods, IRB operations, and regulations and policies governing the protection of human subjects in research. Demonstrated high productivity and quality levels in preparing and processing IRB submissions. Demonstrated navigational expertise in Buck IRB. We strongly encourage applicants submit both a resume and a cover letter.

Salary

The pay range for this job profile is $55,700.00 - $72,700.00.

Institution Name

The Ohio State University