Research Regulatory Analyst I (core)

Summary

UF Research Core Classification* 

Responsible for auditing research activities to ensure that studies are being conducted in accordance with University policies and Federal Regulations. Assist with maintaining quality assurance/compliance programs for the office and developing and implementing procedures for monitoring the compliance process.

Examples of Work

Job functions are specific duties that would be included in the essential functions of the job description.  These functions are not all-inclusive nor do they cover the full extent of the duties performed.

• Audit research protocol files, documents, and systems, as applicable for compliance.
• Assist investigators in complying with policies.
• Assist in Development of Quality Assurance/compliance policies and procedures.
• Report compliance issues to the applicable compliance board/office.
• Network with the other compliance analysts, and compliance offices as to facilitate compliance activities.
• Review submissions and verify that protocol documents concur with the grant/agreement, notify the granting agency or administrator of changes as appropriate.
• Verify that submissions for research subject to compliance rules/regulations contain the elements required for compliance.
• Review research submissions and check the training of the individuals involved.
• Review changes to protocols, informed consent forms and/or other study documents.
• Approve administrative changes to a protocol, including personnel changes, title changes and other administrative approvals as appropriate for the office.
• Draft study specific compliance language for the study as applicable to the office.
• Conduct/coordinate required inspection/investigation of research facilities/activities.

Education and Experience

Bachelor’s degree in an appropriate area; or an equivalent combination of education and experience.

Licensure and Certification

N/A

Supervision

*Reserved Classification – Use of this classification outside of UF Division of Research Compliance (DRC) or UF College of Medicine Research Administration & Compliance (RAC) requires prior approval by Classification and Compensation

This position may include supervisory responsibility.

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