IRB Protocol Analyst II

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Job Title:

IRB Protocol Analyst II

Department:

ERIK | Office of Responsible Research Practices

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.

Additional Information:

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

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: S2

Location:

Mount Hall (0311)

Position Type:

Regular

Scheduled Hours:

40

Shift:

First Shift

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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.