Research Regulatory Analyst III
Research Regulatory Analyst III
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Research Regulatory Analyst III
Inspecting protocol files and subject binders. Implementing the UF Research Monitoring Program which includes planning organizing and conducting directed and random postapproval project inspections to ensure investigator compliance with relevant HHS and FDA regulations institutional and IRB policies and guidelines for the protection of research participants. Monitoring the consent process for compliance with protocol specifications and human subjects protection regulations is a component of the Research Monitoring Program. Encouraging Institutional IRB and investigator compliance by identifying variances that occur when implementing research activities proactively addressing these issues and providing guidance in their resolution. Providing findings and feedback to research teams and the institution is integral to this initiative.
Review of IRB submissions (new submissions modifications) to evaluate proposal content and compliance with Federal and State regulations and UF policies. Assisting investigators in preparing protocols for IRB review including recommending changes and communicating outcome of review.
Coordinate with IRB prereviewers in the prereview of research; identify and (resources permitting) help resolve issues in research relating to Federal Regulations IRB policies and other regulatory requirements or compliance needs.
Intra and inter office communication including listserv to address researcher needs and inquiries about the IRB matters including myIRB assistance ICF and protocol assistance.
Coordinating the UF component of Human Research Protection Accreditation initiatives which includes gap analysis and benchmarking with accredited organizations top academic research institutions and governmental agencies. This activity may vary in the amount of time necessary to achieve the organizational goal depending on accreditation cycle.
Liaison with Investigators and their staff and affiliated research compliance personnel. Educating research teams oneonone in small groups and in formal classes on ethical guidelines and federal regulations pertaining to human subjects protection Guidelines for Good Clinical Practice and IRB/Institutional policies and procedures.
Reporting compliance issues that are discovered to the applicable IRB. Developing maintaining and revising IRB Policies and Procedures forms and guidance documents for compliance with applicable federal state and local laws and regulations.
Duties as assigned
Salary commensurate with experience and expertise.
Masters degree in an appropriate area and one year of relevant experience; or a bachelors degree in an appropriate area and three years of relevant experience; or an equivalent combination of education and experience.
Prior experience in human subjects research; human subject protection program/s or research coordinator experience.
In order to be considered applicants must provide a cover letter resume and a list of professional references.
A criminal background check is required.
Application must be submitted by 11:55 p.m. (ET) of the posting end date.
This requisition has been reposted. Previous applicants are still under consideration and need not reapply.
Required Experience:
IC
Employment Type
Full-Time
