Sr Regulatory and Compliance Officer

The Ohio State University • Columbus, OH

20h • Onsite

About The Position

The Senior Regulatory Compliance Officer assists the Regulatory Compliance Lead, with the oversight and monitoring of the regulatory research compliance function across the research center with support from the Associate Director, Operations C4N for projects being conducted in C4N and serves as a subject matter expert, coordinates and guides the review and approval process for complicated research protocols with a focus on investigator-initiated and federally funded protocols; provides regulatory expertise to ensure research protocols are in compliance with university, state and federal regulations; develops and prepares complex protocol submissions to local and national Institutional Review Boards (IRB); serves as a unit resource for development of IRB documents and for guidance on IRB communications which includes participation in mentoring and training activities; oversees and ensures timely submission of protocol documents for review by appropriate agency; communicates with sponsors of industry, federal, collaborative, and investigator-initiated research projects to address concerns and ensure compliance; establishes and oversees tracking system to continually monitor progress of protocol review and status of approval and ensures regulatory submission timelines are met; manages regulatory data entry into the OnCore database, if applicable; participates in the creation and delivery of onboarding and educational training programs, tools and materials; continually monitors federal and sponsor rules, regulations and processes to identify and interpret new, updated or changed requirements; provides regulatory updates to investigators and research staff of new or changed regulations; leads the development of and provides required regulatory reports and associated documentation; engages in regular monitoring of regulatory files in conjunction with investigators and research staff; conducts audits with special emphasis on investigator-initiated and federally funded protocols.

Requirements

• Bachelor's degree or equivalent experience.
• 4 years of relevant experience required.
• Knowledge of clinical research regulations and compliance issues especially related to the use of human and animal subjects required.
• Requires successful completion of a background check.

Nice To Haves

• Advanced degree in relevant field may be desirable.
• 4-8 years of relevant experience preferred.
• Experience and knowledge of federal & industry research sponsor requirements preferred.
• Experience in a regulatory affairs capacity in a medical or research setting desired.
• Experience in protocol development desired.

Responsibilities

• Assists the Regulatory Compliance Lead with oversight and monitoring of regulatory research compliance.
• Serves as a subject matter expert, coordinating and guiding the review and approval process for complicated research protocols.
• Provides regulatory expertise to ensure research protocols comply with regulations.
• Develops and prepares complex protocol submissions to local and national Institutional Review Boards (IRB).
• Serves as a unit resource for IRB document development and guidance on IRB communications.
• Oversees and ensures timely submission of protocol documents for review.
• Communicates with sponsors to address concerns and ensure compliance.
• Establishes and oversees a tracking system to monitor protocol review progress and approval status.
• Manages regulatory data entry into the OnCore database, if applicable.
• Participates in creating and delivering onboarding and educational training programs.
• Monitors federal and sponsor rules, regulations, and processes to identify and interpret new requirements.
• Provides regulatory updates to investigators and research staff.
• Leads the development of regulatory reports and documentation.
• Engages in regular monitoring of regulatory files.
• Conducts audits with a focus on investigator-initiated and federally funded protocols.

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