The IRB Protocol Analyst 1 assists in oversight of regulated human research submissions of limited scope and complexity; assists in the coordination of Institutional Review Board (IRB, Board) member activities; understands and applies basic concepts of federal regulations, state laws, and human research protection program policies to ensure compliance with sponsor and university requirements; follows prescribed procedures to analyze research submissions and provide guidance to principal investigators and research teams; documents regulatory findings, Board deliberations and actions under the supervision of experienced Analysts; assists in coordinating 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; assists in identifying customer service needs; participates in business process improvement initiatives and assists in the development of educational programs; assists in the conduct of training sessions for research teams and IRB members; operates within electronic submission system for communications and document management.
Required Qualifications:
- Bachelor’s degree or equivalent combination of education and 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;
- Good writing and communication skills.
Successful completion of a criminal background check. A drug screening or physical may be required during the post offer process.
Desired Qualifications:
- Knowledge and/or experience with research methods, IRB operations, regulations and policies governing the protection of human subjects in research.
To be considered for this position, a resume and a cover letter are required to be submitted.
Additional Information:
The pay range for this job profile is $43,098.80 – $57,761.60. The offer for this position will fall within this range based on multiple factors including internal equity, unit’s available budget, and the candidate’s qualifications.
Function: Research Administration
Subfunction: Research Protocol
Career Level: S1
