IRB Research Protocol Consultant

The Ohio State University • Columbus, OH

4d • $75,700 - $98,900 • Onsite

About The Position

The IRB Research Protocol Consultant serves as a principal liaison between the university, IRBs, senior institutional leaders, and other applicable internal and external institutional areas. The IRB Research Protocol Consultant: Exercises sound judgment in independently monitoring research analytics to ensure screening timeliness and conformance with federal regulations and guidance, state laws, and institutional policies governing research involving human subjects under the direction of the associate director, IRB operations. Applies ethical principles to resolve complex issues; provides guidance and oversight in the review requirements for complex research submissions; guides ORRP staff and IRB members in making regulatory determinations. Provides professional service to the Institutional Review Board (IRB, Board) and investigators involving the application of ethical principles and concepts. Provides convened meeting training on developing agendas and reviewer assignments, complex and technical deliberations, regulatory findings, and Board actions. Guides protocol analysts to effectively help investigators formulate responses to IRB requests; assists researchers to secure timely IRB approvals. Serves as a leader and subject matter expert in specific regulatory and operational areas, such as collaborative and multi-site research, research review and approval processes, overseeing the management of convened IRB meetings, or applying analytics/metrics to manage staff workflow. Oversees the development and implementation of other human research programs. Supervises review/training activities; monitors and prioritizes workflow, and provides metrics to set team-level targets. Leads business process improvement initiatives and participates in development of applicable education programs; partners with colleges and departments in outreach activities; attends the Public Responsibility In Medicine & Research (PRIM&R) national conference through the conduct of workshops or poster presentations. Oversees electronic submission system testing and makes recommendations for enhancements. Represents ORRP at events and serves as a speaker at education and training events for university units, including the Comprehensive Cancer Center Clinical Trials Office (CCC-CTO), Center for Clinical Research Management (CCRM), College of Nursing, Clinical and Translational Science Institute, and others. Identifies opportunities for continued ORRP staff education and/or training, providing recommendations and feedback to ORRP leadership. Performs education and/or training as needed for junior level staff. Participates in the development of training for senior level staff. Manages new staff recruitment, onboarding, mentoring, and training. Supervises junior level protocol analysts, including providing direction of daily activities, evaluating performance, and setting clear expectations on responsibilities. This search is recruiting for three openings.

Requirements

• Bachelor's degree or an equivalent combination of education and experience.
• 6 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
• Certified IRB Professional certification.

Nice To Haves

• 8-12 years of human subjects regulatory experience or relevant work experience.
• Knowledge of and experience with IRB operations and research methodologies.
• Experience in projects.

Responsibilities

• Exercises sound judgment in independently monitoring research analytics to ensure screening timeliness and conformance with federal regulations and guidance, state laws, and institutional policies governing research involving human subjects under the direction of the associate director, IRB operations.
• Applies ethical principles to resolve complex issues; provides guidance and oversight in the review requirements for complex research submissions; guides ORRP staff and IRB members in making regulatory determinations.
• Provides professional service to the Institutional Review Board (IRB, Board) and investigators involving the application of ethical principles and concepts.
• Provides convened meeting training on developing agendas and reviewer assignments, complex and technical deliberations, regulatory findings, and Board actions.
• Guides protocol analysts to effectively help investigators formulate responses to IRB requests; assists researchers to secure timely IRB approvals.
• Serves as a leader and subject matter expert in specific regulatory and operational areas, such as collaborative and multi-site research, research review and approval processes, overseeing the management of convened IRB meetings, or applying analytics/metrics to manage staff workflow.
• Oversees the development and implementation of other human research programs.
• Supervises review/training activities; monitors and prioritizes workflow, and provides metrics to set team-level targets.
• Leads business process improvement initiatives and participates in development of applicable education programs; partners with colleges and departments in outreach activities; attends the Public Responsibility In Medicine & Research (PRIM&R) national conference through the conduct of workshops or poster presentations.
• Oversees electronic submission system testing and makes recommendations for enhancements.
• Represents ORRP at events and serves as a speaker at education and training events for university units, including the Comprehensive Cancer Center Clinical Trials Office (CCC-CTO), Center for Clinical Research Management (CCRM), College of Nursing, Clinical and Translational Science Institute, and others.
• Identifies opportunities for continued ORRP staff education and/or training, providing recommendations and feedback to ORRP leadership.
• Performs education and/or training as needed for junior level staff.
• Participates in the development of training for senior level staff.
• Manages new staff recruitment, onboarding, mentoring, and training.
• Supervises junior level protocol analysts, including providing direction of daily activities, evaluating performance, and setting clear expectations on responsibilities.

Benefits

• Eligible Ohio State employees receive comprehensive benefits packages, including medical, dental and vision insurance, tuition assistance for employees and their dependents, and state or alternative retirement options with competitive employer contributions.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level