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University of Kentucky

Research Regulatory Specialist III

🇺🇸 Hybrid - Lexington, KY 🕑 Full-Time 💰 $57K - $94K 💻 Compliance 🗓️ March 19th, 2026
IRB

Edtech.com's Summary

University of Kentucky is hiring a Research Regulatory Specialist III. The role involves managing regulatory responsibilities for clinical research protocols including IRB submissions, informed consents, safety reports, and adverse event forms while maintaining compliance with FDA regulations and supporting protocol development.

Highlights
  • Manage and coordinate regulatory data and information for clinical research protocols.
  • Maintain trial management databases and all regulatory records per FDA regulations.
  • Participate in site evaluation, initiation, monitoring, and termination visits.
  • Develop standard operating procedures to improve regulatory compliance and efficiency.
  • Assist in protocol development and ensure coordination with IRB, regulatory, and financial specializations.
  • Must understand Good Clinical Practice (GCP), NIH and FDA regulations.
  • Requires BS degree and 4 years of related experience; certification (SOCRA, ACRP) preferred.
  • Salary range: $57,158 - $94,286 per year.
  • Full-time staff position with Monday-Friday schedule, some overtime possible.
  • Position offers a hybrid work arrangement.

Research Regulatory Specialist III Full Description

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Posting Details
Posting Details
Job Title Research Regulatory Specialist III
Requisition Number RE53245
Working Title RRS III
Department Name 7H024:MCC - CLINICAL RESEARCH ORG
Work Location Lexington, KY
Grade Level 47
Salary Range $57,158-94,286/year
Type of Position Staff
Position Time Status Full-Time
Required Education
BS
Click here for more information about equivalencies: https://hr.uky.edu/employment/working-uk/equivalencies
Required Related Experience
4 yrs
Required License/Registration/Certification
None
Physical Requirements
Requires handling of light-weight objects up to 10 pounds, sitting for long periods of time, some standing or walking, repetitive motion.
Shift
Monday-Friday, 8:00am-4:30pm (40hrs wk), Some overtime may be required.
Job Summary
The Markey Cancer Center, Clinical Research Org. (CRO) is seeking to hire a Research Regulatory Specialist III (RRS III). The RRS III accepts research responsibility with guidance from the Principal Investigator(s) and the Research Administration and Operations Director. The RRS III is responsible for obtaining and coordinating data and other required information needed to fulfill all the regulatory requirements for protocols, including IRB submissions, informed consents, safety reports, and adverse event forms. Maintain all regulatory records as per FDA regulations. Maintain trial management databases required for each protocol. Ensure accuracy and completeness of regulatory records and verify ongoing studies are completed in accordance with applicable FDA regulations. Will participate in site evaluation, initiation, monitoring and termination visits. Develop standard operating procedures for regulatory activities to improve compliance and efficiency. Will assist in protocol development. The individual in this position will be expected to have an understanding of how the different areas of specialization (regulatory, IRB, financial) work together in the management of clinical research studies and protocols.

This position will have a Hybrid work arrangement.

IMPORTANT: Resumes and CVs cannot be substituted for a completed application. Incomplete applications could disqualify you from being considered for this position. To be considered you must fully complete the online application being sure to only put one (1) job title for each entry (multiple job titles for one employer must have separate entries), the # of hours worked per week and your ending salary. You will also be required to upload a cover letter and resume.

To view our exceptional benefits, please visit https://www.uky.edu/hr/benefits.
Skills / Knowledge / Abilities
Comprehensive understanding of regulatory requirements for human subject research, including Good Clinical Practice (GCP), Responsible Conduct of Research, NIH and FDA regulations and procedures. Effective oral and written communication. Organization, collaboration, attention to detail, time management, and ability to multi-task. Work independently and navigate institutional and external resources. Critical thinking and problem solving. Ability to teach/coach and lead teams. Serves as a mentor for RRS I and II. Review and assess work for quality and compliance.
Does this position have supervisory responsibilities? No
Preferred Education/Experience
Bachelors degree and four years of related experience or UK equivalencies. Certification preferred (SOCRA, ACRP, etc.)
Deadline to Apply 04/01/2026
Our University Community
We value the well-being of each of our employees and are dedicated to creating a healthy place for everyone to work, learn and live. In the interest of maintaining a safe and healthy environment for our students, employees, patients and visitors, the University of Kentucky is a Tobacco & Drug Free campus.

The University follows both the federal and state Constitutions as well as all applicable federal and state laws on nondiscrimination. The University provides equal opportunities for qualified persons in all aspects of institutional operations and does not discriminate on the basis of race, color, national origin, ethnic origin, religion, creed, age, physical or mental disability, veteran status, uniformed service, political belief, sex, sexual orientation, gender identity, gender expression, pregnancy, marital status, genetic information or social or economic status.

Any candidate offered a position may be required to pass pre-employment screenings as mandated by University of Kentucky Human Resources. These screenings may include a national background check and/or drug screen.
Posting Specific Questions

Required fields are indicated with an asterisk (*).

  1. * How many years experience do you have working with protocol submissions, IRB's, patient consents?
    • None
    • More than 0, up through 1 year
    • More than 1 year, up through 3 years
    • More than 3 years, up through 5 years
    • More than 5 years
  2. * Describe your experience working with clinical research as a Research Regulatory Specialist

    (Open Ended Question)

Applicant Documents
Required Documents
  1. Resume
  2. Cover Letter

Optional Documents

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