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Research Regulatory Analyst III

2 months ago

Gainesville, Florida, United States InsideHigherEd Full time
Job Summary

We are seeking a highly skilled Research Regulatory Analyst III to join our team at InsideHigherEd. The successful candidate will be responsible for ensuring compliance with relevant regulations and guidelines in human subjects research.

Key Responsibilities
  • Inspecting protocol files and subject binders to ensure compliance with regulations and guidelines.
  • Implementing the UF Research Monitoring Program, which includes planning, organizing, and conducting directed and random post-approval project inspections.
  • Monitoring the consent process for compliance with protocol specifications and human subjects' protection regulations.
  • Encouraging Institutional, IRB, and investigator compliance by identifying variances and providing guidance in their resolution.
  • Providing findings and feedback to research teams and the institution.
  • Reviewing IRB submissions 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.
  • Coordinating with IRB pre-reviewers in the pre-review of research and identifying and resolving issues related to Federal Regulations, IRB policies, and other regulatory requirements or compliance needs.
  • Educating research teams on ethical guidelines and federal regulations pertaining to human subjects' protection, Guidelines for Good Clinical Practice, and IRB/Institutional policies and procedures.
  • Developing, maintaining, and revising IRB Policies and Procedures, forms, and guidance documents for compliance with applicable federal, state, and local laws and regulations.
Requirements
  • 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.
  • Prior experience in human subjects research; human subject protection program/s or research coordinator experience.
What We Offer

We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.