University of Kentucky
Research Regulatory Specialist II
🇺🇸 Lexington, KY
🕑 Full-Time
💰 $25 - $41 per Hour
💻 Research
🗓️ June 16th, 2025
Edtech.com's Summary
- Assist in conducting research procedures for clinical trials in the Pediatrics Research department.
- Manage study documentation, protocol submissions, and SOP adherence with minimal supervision.
- Maintain organized regulatory documentation for complex studies in compliance with federal, state, and local regulations.
- Prepare and manage IRB submissions, including initial reviews and protocol modifications.
- Independently maintain site training and compliance records.
- Coordinate and participate in site visits for study initiation, monitoring, and closeout.
- Serve as a liaison between IRB, sponsors, and study teams.
- Knowledge required: Good Clinical Practice (GCP), NIH and FDA regulations, and clinical research policies.
- Preferred qualifications: Bachelor’s degree with 2+ years related experience and research certification (SOCRA, ACRP preferred).
- Compensation: $25.01 to $41.25 per hour, full-time position with flexible schedule.
Research Regulatory Specialist II Full Description
Requisition Number | RE50496
Working Title |
Department Name | 7H667:PEDIATRICS - RESEARCH
Work Location | Lexington, KY
Grade Level | 46
Salary Range | $25.01-41.25/hour
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 | 2 yrs
Required License/Registration/Certification | N/A
Physical Requirements
Ability to sit for long periods of time, repetitive motion, lifting, pushing and pulling on objects up to 30 lbs, possible standing and walking several hundred feet per day. This position requires study coordination and interaction with research participants. Processing of blood and use of dry ice.
Shift | Monday – Friday 40 hours. Requires flexible schedule to accommodate research needs.
Job Summary
The department of Pediatrics Research is seeking a Research Regulatory Specialist II. This position will primarily assist in the performance of research procedures in clinical trials.
Essential duties of this position include, but are not limited to knowledge of regulatory and institutional policies and processes; apply appropriately to study documentation, protocol submissions, and SOPs with minimal supervision; use best practice standards to maintain current and organized study-level documentation, including internal and external regulatory documents, for all studies, including those that are complex (e.g., procedural and interventional studies), in accordance with federal, state, and local regulations and guidelines; integrate information from multiple sources and use specialized regulatory knowledge of the governing clinical research policies to ensure assigned clinical trials are compliant with applicable federal and institutional regulations.
Must also be able to manage, develop, and prepare IRB submissions, initial reviews, protocol modifications, and continuation or final reviews; independently maintain site training and compliance records; prepare for, coordinate, and actively participate in site visits for initiation, monitoring, and close out; serve as a liaison between IRB, sponsor, and study teams; as well as create and maintain regulatory logs.
Skills / Knowledge / Abilities
Knowledge 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, attention to detail, time management, and ability to multi-task. Demonstrate critical thinking and problem-solving skills. Work independently and navigate institutional resources.
Does this position have supervisory responsibilities? | No
Preferred Education/Experience | Bachelor’s degree and at least 2 years of related experience. Research certification (SOCRA, ACRP, etc.) preferred. Research certification (SOCRA, ACRP, etc.) preferred.
Deadline to Apply | 06/15/2025
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.
As an Equal Opportunity Employer, we strongly encourage veterans, individuals with disabilities, women, and all minorities to consider our employment opportunities.
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.
- * Do you have experience working with clinical research?
- Yes
- No
- * Have you received training or formal courses in health behavior and/or courses related to maternal child health?
- Yes
- No
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