The Senior IRB Protocol Analyst exercises sound judgment in independently reviewing and monitoring research submissions to ensure conformance with federal regulations and guidance, state laws, and institutional policies governing research involving human subjects; applies ethical principles to resolve complex issues; independently advises investigators on satisfying review requirements for complex research submissions; contacts agencies to clarify regulations and guidance; makes independent regulatory determinations; consults local experts and evaluates international research settings for human subjects research; provides professional service to the Institutional Review Board (IRB, Board) and investigators involving the application of ethical principles and concepts; monitors conflicts of interest; approves agenda and reviewer agreements; documents complex and technical deliberations, regulatory findings, and board actions; assists investigators in formulating responses to board requests; assists researchers to secure timely Board approvals; may serve as a subject matter expert in specific regulatory areas, such as Food and Drug Administration regulations, devices, classroom education research, and others; develops training programs and conducts educational sessions on the ethical conduct of human subjects research for student and faculty researchers and IRB members; provides guidance and serves as a coach and mentor to protocol analysts; works with IRB associate directors to monitor and prioritize workflow, and to set team-level targets; assists protocol analysts in prioritizing their day-to-day work assignments and individual targets; actively participates in business process improvement initiatives and participates in development of education programs; establishes and participates in cross-unit teams to develop effective procedures and associated training materials; partners with colleges and departments in educational and outreach activities; attends the Public Responsibility In Medicine & Research (PRIM&R) national conferences and submits proposals to conduct workshops or poster presentations; attends IRB Policy Committee meetings as necessary; assists in electronic submission system testing and makes recommendations for enhancements; serves as a cross-functional operations team member, possesses the ability to manage all university IRBs; participates in ORRP events and serves as a speaker at education and training events for university units such as the Cancer Clinical Trials Office (CTO), Center for Clinical Research Management (CCRM), College of Social Work, and others; participates in ORRP office hours; presents or contributes to discussions at IRB and IPC meetings.
Required Qualifications:
- Bachelor’s degree or equivalent combination of education & experience;
- 4 years of relevant work experience; experience in IRB operations;
- Knowledge of and experience applying regulations governing research involving human subjects;
- Strong problem solver and customer service experience;
- Proficient in the use of Microsoft Office suite;
- Ability to work within a regulatory and deadline-driven environment;
Successful completion of a criminal background check. A drug screening or physical may be required during the post offer process.
Desired Qualifications:
- 4-8 years of human subjects regulatory experience or relevant work experience;
- Knowledge of and experience with IRB operations and research methodologies; experience in projects;
- Certified IRB Professional certification.
We strongly encourage that applicants submit both a resume and a cover letter.
Additional Information:
The pay range for this job profile is $ $69,400 – $91,250.00. 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.
Employees are provided several flexible work schedule and location options aligned with U.S. Eastern Time Zone including an option for remote. All employees are provided university-configured equipment and supportive technology tools. Employees are required to provide reliable internet access and home office furnishings for approved remote work locations.
Function: Research Administration
Subfunction: Research Protocol
Career Level: S3
