Regulatory Compliance Analyst 3

The Ohio State University • Columbus, OH

1d • Onsite

About The Position

Regulatory Compliance Analyst 3 assists the Deputy Director with the oversight and monitoring of the regulatory research compliance function across the State of Ohio Adversity and Resilience Studies (SOAR) and serves as a subject matter expert, coordinates and guides the review and approval process for 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 resource for development of IRB documents and for guidance on IRB communications which includes participation in 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 and/or clinical research certification 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 Deputy Director with the oversight and monitoring of the regulatory research compliance function across the State of Ohio Adversity and Resilience Studies (SOAR)
• Serves as a subject matter expert, coordinates and guides the review and approval process for 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 resource for development of IRB documents and for guidance on IRB communications which includes participation in 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.

Benefits

• Medical, dental and vision coverage, with Ohio State paying a significant portion of the cost.
• Paid time off, including sick and vacation time and 11 holidays.
• State retirement plan or an alternative retirement plan, both with generous employer contributions.

What This Job Offers

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