Research Regulatory Specialist II

Job Title
Research Regulatory Specialist II


Requisition Number
RE51185


Working Title
RRS II/Regulatory


Department Name
7H024:MCC - CLINICAL RESEARCH ORG


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

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 Organization, is recruiting for a Research Regulatory Specialist II (RRS II – Regulatory). This position accepts research responsibility with guidance from the Principal Investigator(s) and the Research Admin & Operations Director. The RRS II-Regulatory 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 has 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. If the information on your resume is not entered on the application, this will prevent us from being able to assess your education and experience when trying to determine a salary offer. 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

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

Bachelors degree and two years of related experience or UK equivalencies. Research Certification preferred (SOCRA, ACRP, etc.).



Deadline to Apply
08/19/2025


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.