Research Regulatory Analyst III (core)

Summary

UF Research Core Classification* 

Performs highly professional and responsible work in a core compliance office. Normally reports directly to an Associate/Assistant Director. Responsible for developing and maintaining programs to ensure compliance with applicable regulations. Develops and implements procedures for complying with applicable regulations and monitoring compliance of approved research protocols. Responsible for ensuring that principal investigators are aware of the regulations and their responsibility in complying with the applicable regulations. Is a resource for office staff and investigators on compliance related issues.

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.

• Serve as administrative expert for pre- and/or post-review of research; conduct/coordinate the compliance pre-review of covered research; identify and help resolve issues in research relating to compliance needs and other regulatory requirements; work with other compliance offices on related issues.
• Assist compliance office administrators and staff as needed.
• Assist faculty in preparing submissions for review: evaluate applicable compliance aspects of protocols and study documents; provide technical assistance in the completion of submissions, revisions, renewals, and adverse events reporting.
• Preview/Review research submissions for completeness and correctness.
• Review and approve research that meets exemptions and other compliance criteria, as applicable to the compliance office.
• Interact with faculty, staff, students, and administrative faculty to resolve any issues, which may result from reviews.
• Serve as regulatory expert; stay informed on any upcoming changes to compliance regulations; assist in developing policies to insure compliance; liaison with other research compliance offices; develop and implement educational materials for the research community as appropriate.
• Assist in the interpretation of federal and state laws and regulations, agency rules and guidelines, and university policies and procedures regarding the compliance program in order to produce training and educational programs and program materials for faculty, staff, administrators and sponsors.
• Participate in education of staff, board members and other research community outreach efforts as applicable to the compliance office.
• Conduct group and one-on-one training sessions for investigators/study staff on submission requirements and research compliance.
• Manage communications with investigative staff, and new board members (if applicable). Monitor, investigate, and collaborate with investigators and other stakeholders in the identification and resolution of compliance issues.
• Develop and direct educational programs that lead to UF certification in areas with federal, state, and University oversight including electronic record keeping and on-line reporting of the status of researcher and staff certification, as applicable to the compliance office.
• Recommend and formulate new or revised policies and procedures, training, and instruction to ensure University compliance with research related requirements.
• Collaborate with other departments/programs to implement processes to support research compliance.
• Develop public relations and/or training programs as well as University requirements for participation as applicable to the compliance office.

Education and Experience

Master’s degree in an appropriate area and one year of relevant experience; or a bachelor’s degree in an appropriate area and three years of relevant experience; 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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