Research Regulatory Specialist II

Edtech.com's Summary

University of Kentucky is hiring a Research Regulatory Specialist II. This role manages regulatory requirements for clinical research protocols, including coordinating data for IRB submissions, informed consents, safety reports, and adverse event forms. The specialist maintains compliance with FDA regulations, participates in site visits, develops procedures to improve regulatory activities, and assists in protocol development within the Clinical Research Organization at Markey Cancer Center.

Highlights

Manage regulatory processes including IRB submissions, informed consents, safety reports, and adverse event documentation.
Maintain regulatory records and trial management databases adhering to FDA guidelines.
Participate in site evaluation, initiation, monitoring, and termination visits.
Develop standard operating procedures to improve compliance and efficiency of regulatory activities.
Assist in the development of clinical research protocols.
Requires knowledge of Good Clinical Practice (GCP), NIH and FDA regulations, and Responsible Conduct of Research.
Preferred qualifications include a Bachelor's degree, at least 2 years of related experience, and research certification such as SOCRA or ACRP.
Salary range is $25.01 to $41.25 per hour.
Work schedule is full-time Monday to Friday, 8:00 am to 4:30 pm, with some overtime possible.
Position is part of the Markey Cancer Center's Clinical Research Organization and features a hybrid work arrangement.

Research Regulatory Specialist II Full Description

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Posting Details

Job Title	Research Regulatory Specialist II
Requisition Number	RE53237
Working Title	RRS II - Reg
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 (40 hours per week). 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	Bachelor’s degree and at least 2 years of related experience. Research certification (SOCRA, ACRP, etc.) preferred.
Deadline to Apply	05/20/2026
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 (*).

* Please select the answer that best describes your years of paid, full-time employment experience in clinical research.
- None
- More than 0 years, up through 1 year
- More than 1 year, up through 3 years
- More than 3 years, up through 7 years
- More than 7 years, up through 10 years
- More than 10 years
* Please choose the answer that best describes your years of paid, full-time employment experience working with protocol submissions, IRB's, and patient consents.
- None
- 1 - 3 years
- 3 - 5 years
- Over 5 years

Applicant Documents

Required Documents

Resume
Cover Letter

Optional Documents

805 Las Cimas Parkway Suite 400 Austin, Texas, 78746

© University of Kentucky
Lexington, Kentucky 40506
An Equal Opportunity University
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Original Job Description

Toggle navigation

Applicant Support

Research Regulatory Specialist II Bookmark this Posting Print Preview | Apply for this Job

Posting Details

Job Title	Research Regulatory Specialist II
Requisition Number	RE53237
Working Title	RRS II - Reg
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 (40 hours per week). 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	Bachelor’s degree and at least 2 years of related experience. Research certification (SOCRA, ACRP, etc.) preferred.
Deadline to Apply	05/20/2026
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 (*).

* Please select the answer that best describes your years of paid, full-time employment experience in clinical research.
- None
- More than 0 years, up through 1 year
- More than 1 year, up through 3 years
- More than 3 years, up through 7 years
- More than 7 years, up through 10 years
- More than 10 years
* Please choose the answer that best describes your years of paid, full-time employment experience working with protocol submissions, IRB's, and patient consents.
- None
- 1 - 3 years
- 3 - 5 years
- Over 5 years

Applicant Documents

Required Documents

Resume
Cover Letter

Optional Documents

805 Las Cimas Parkway Suite 400 Austin, Texas, 78746

Lexington, Kentucky 40506
An Equal Opportunity University
Accreditation
Directory
Email
Privacy Policy

To ensure the security of your data, you will be logged out due to inactivity in 3 minutes at
.

Any data not saved will be lost.

Click 'OK' to keep your session active.

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Research Regulatory Specialist II

Edtech.com's Summary

Research Regulatory Specialist II Full Description

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