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Job Title:
Senior IRB Protocol Analyst
Department:
ERIK | Office of Responsible Research Practices
Job Overview:
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 Education and Experience:
- 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 solving and customer service experience.
- Proficient in the use of Microsoft Office suite.
- Ability to work within a regulatory and deadline-driven environment.
Desired Education and Experience:
- 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 applicants submit both a resume and a cover letter.
Additional Information:
The pay range for this job profile is $70,100.00 - $91,600.00. The offer for this position will fall within this range based on multiple factors including internal equity, unit's available budget and the selected candidate's qualifications.
There are multiple positions available with this posting.
ERIK Overview:
Join the Enterprise for Research, Innovation and Knowledge (ERIK) at The Ohio State University and become a part of a dynamic, forward-thinking team dedicated to pushing the boundaries of discovery and innovation. ERIK positions Ohio State to expand curiosity-driven research and creative expression, further develop our research community of faculty, staff, and students, and grow the innovation ecosystem to address big challenges and improve communities locally and globally. We are seeking passionate individuals who are committed to making a meaningful impact through collaboration, innovation, and excellence. To learn more about our mission and work, please visit https://erik.osu.edu/.
Position Mapping:
Function: Research Administration
Subfunction: Research Protocol
Career Level: S3
Location:
Mount Hall (0311)
Position Type:
Regular
Scheduled Hours:
40
Shift:
First Shift
Final candidates are subject to successful completion of a background check. A drug screen or physical may be required during the post offer process.
Thank you for your interest in positions at The Ohio State University and Wexner Medical Center. Once you have applied, the most updated information on the status of your application can be found by visiting the Candidate Home section of this site. Please view your submitted applications by logging in and reviewing your status. For answers to additional questions please review the frequently asked questions.
The university is an equal opportunity employer, including veterans and disability.
As required by Ohio Revised Code section 3345.0216, Ohio State will: educate students by means of free, open and rigorous intellectual inquiry to seek the truth; equip students with the opportunity to develop intellectual skills to reach their own, informed conclusions; not require, favor, disfavor or prohibit speech or lawful assembly; create a community dedicated to an ethic of civil and free inquiry, which respects the autonomy of each member, supports individual capacities for growth and tolerates differences in opinion; treat all faculty, staff and students as individuals, hold them to equal standards and provide equality of opportunity with regard to race, ethnicity, religion, sex, sexual orientation, gender identity or gender expression.
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