Research Regulatory Manager

Edtech.com's Summary

University of Kentucky is hiring a Research Regulatory Manager. This role involves demonstrating subject matter expertise in HSP, RCR, HIPAA, and GCP standards, overseeing regulatory staff, managing IRB submission processes, and ensuring compliance with institutional and federal regulations to support clinical research activities.

Highlights

Manage and provide expertise on clinical research regulations including HSP, RCR, HIPAA, and Good Clinical Practice (GCP) standards.
Oversee the IRB submission, maintenance, and close-out processes, ensuring accuracy and timeliness.
Prepare regulatory submissions for UK IRB, Central IRB, FDA, and other regulatory entities throughout study lifecycles.
Lead and supervise Regulatory Knowledge and Support Core staff and oversee regulatory recharge processes aligned with cost accounting standards.
Requires proficiency in Microsoft Office applications, especially in designing forms and spreadsheets.
Must have a Master's degree, at least 6 years of clinical or clinical research experience, with research certification preferred.
Strong leadership, communication, organizational, and problem-solving skills are essential.
Salary range of $62,941 to $103,834 per year with a full-time staff position status.
Position is hybrid-eligible, supporting both remote and in-person work arrangements.
Supports the Center for Clinical and Translational Science's mission to enhance health outcomes and advance translational research across Kentucky communities.

Research Regulatory Manager Full Description

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Posting Details

Job Title	Research Regulatory Manager
Requisition Number	RE54369
Working Title
Department Name	40833:CCTS Clinical Research Dev & Ops Center
Work Location	Lexington, KY
Grade Level	48
Salary Range	$62,941-103,834/year
Type of Position	Staff
Position Time Status	Full-Time
Required Education	MA
Click here for more information about equivalencies:	https://hr.uky.edu/employment/working-uk/equivalencies
Required Related Experience	6 yrs
Required License/Registration/Certification	None
Physical Requirements	Light lifting up to 25 lbs., long hours at computer station, high levels of concentration for most tasks.
Shift	Normal daytime shift
Job Summary	The Center for Clinical and Translational Science (CCTS) is seeking a highly motivated, professional Research Regulatory Manager to contribute to the variety of perspectives and excellence of our department and to assist the faculty and staff of our fast-paced research center. The CCTS helps campus research professionals meet their goals and improve health outcomes across Kentucky communities. Our vision is to foster collaboration and innovation in healthcare, education, research, and community partnerships. We are committed to advancing translational research that improves public health, particularly in regions with limited access to care. Since its inception in 2006, the CCTS has invested millions of dollars in research funding and trainee support at the University of Kentucky through its commitment to funding innovative, early stage translational research. In support of that vision, the Research Regulatory Manager role will serve as a team member of the Regulatory Knowledge and Support Core. Responsibilities for this position include the ability to demonstrate subject matter expertise in HSP, RCR, HIPAA, and Good Clinical Practice (GCP) standards; expert knowledge of institutional, local, state and federal regulations as they relate to clinical research. Orchestrate applicable training for team members; assess and determine solutions for regulatory shortcomings of protocols, as appropriate. The employee will oversee RRS staff to ensure the IRB submission, maintenance and close-out process is completed accurately and in a timely fashion; may prepare UK IRB, Central IRB, FDA and other regulatory submissions for initial study start-up, annual reviews, and modifications required throughout study lifecycle and oversee regulatory unit recharge process to ensure that time and procedures are tracked and billed appropriately to grant accounts according to cost accounting standards. Successful candidates will possess comprehensive understanding of related scientific, clinical and regulatory terminology. Ability to independently identify and problem-solve complex/non-routine problems. Strong organizational skills with attention to detail, strong oral/written communication skills, and strong interpersonal skills required. Demonstrate leadership, personnel management, task prioritization, and presentation skills. Computer and web-based application proficiency to include designing forms and spreadsheets using Microsoft Office applications. The CCTS is dedicated to broadening the range of perspectives within our staff and faculty and aims to build a team with an extensive spectrum of skills and experiences. The position will be hybrid-eligible (remote and in-person). The CCTS encourages all qualified candidates to apply.
Skills / Knowledge / Abilities	Comprehensive understanding of related scientific, clinical and regulatory terminology. Ability to independently identify and problem-solve complex/non-routine problems. Strong organizational skills with attention to detail, strong oral/written communication skills, and strong interpersonal skills required. Demonstrate leadership, personnel management, task prioritization, and presentation skills. Computer and web-based application proficiency to include designing forms and spreadsheets using Microsoft Office applications.
Does this position have supervisory responsibilities?	Yes
Preferred Education/Experience	Master’s degree and at least 6 years of clinical or clinical research experience. Research certification (SOCRA, ACRP, etc.) preferred.
Deadline to Apply	06/01/2026
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.

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Cover Letter

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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

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Applicant Support

Research Regulatory Manager Bookmark this Posting Print Preview | Apply for this Job

Posting Details

Job Title	Research Regulatory Manager
Requisition Number	RE54369
Working Title
Department Name	40833:CCTS Clinical Research Dev & Ops Center
Work Location	Lexington, KY
Grade Level	48
Salary Range	$62,941-103,834/year
Type of Position	Staff
Position Time Status	Full-Time
Required Education	MA
Click here for more information about equivalencies:	https://hr.uky.edu/employment/working-uk/equivalencies
Required Related Experience	6 yrs
Required License/Registration/Certification	None
Physical Requirements	Light lifting up to 25 lbs., long hours at computer station, high levels of concentration for most tasks.
Shift	Normal daytime shift
Job Summary	The Center for Clinical and Translational Science (CCTS) is seeking a highly motivated, professional Research Regulatory Manager to contribute to the variety of perspectives and excellence of our department and to assist the faculty and staff of our fast-paced research center. The CCTS helps campus research professionals meet their goals and improve health outcomes across Kentucky communities. Our vision is to foster collaboration and innovation in healthcare, education, research, and community partnerships. We are committed to advancing translational research that improves public health, particularly in regions with limited access to care. Since its inception in 2006, the CCTS has invested millions of dollars in research funding and trainee support at the University of Kentucky through its commitment to funding innovative, early stage translational research. In support of that vision, the Research Regulatory Manager role will serve as a team member of the Regulatory Knowledge and Support Core. Responsibilities for this position include the ability to demonstrate subject matter expertise in HSP, RCR, HIPAA, and Good Clinical Practice (GCP) standards; expert knowledge of institutional, local, state and federal regulations as they relate to clinical research. Orchestrate applicable training for team members; assess and determine solutions for regulatory shortcomings of protocols, as appropriate. The employee will oversee RRS staff to ensure the IRB submission, maintenance and close-out process is completed accurately and in a timely fashion; may prepare UK IRB, Central IRB, FDA and other regulatory submissions for initial study start-up, annual reviews, and modifications required throughout study lifecycle and oversee regulatory unit recharge process to ensure that time and procedures are tracked and billed appropriately to grant accounts according to cost accounting standards. Successful candidates will possess comprehensive understanding of related scientific, clinical and regulatory terminology. Ability to independently identify and problem-solve complex/non-routine problems. Strong organizational skills with attention to detail, strong oral/written communication skills, and strong interpersonal skills required. Demonstrate leadership, personnel management, task prioritization, and presentation skills. Computer and web-based application proficiency to include designing forms and spreadsheets using Microsoft Office applications. The CCTS is dedicated to broadening the range of perspectives within our staff and faculty and aims to build a team with an extensive spectrum of skills and experiences. The position will be hybrid-eligible (remote and in-person). The CCTS encourages all qualified candidates to apply.
Skills / Knowledge / Abilities	Comprehensive understanding of related scientific, clinical and regulatory terminology. Ability to independently identify and problem-solve complex/non-routine problems. Strong organizational skills with attention to detail, strong oral/written communication skills, and strong interpersonal skills required. Demonstrate leadership, personnel management, task prioritization, and presentation skills. Computer and web-based application proficiency to include designing forms and spreadsheets using Microsoft Office applications.
Does this position have supervisory responsibilities?	Yes
Preferred Education/Experience	Master’s degree and at least 6 years of clinical or clinical research experience. Research certification (SOCRA, ACRP, etc.) preferred.
Deadline to Apply	06/01/2026
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 (*).

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

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Research Regulatory Manager

Edtech.com's Summary

Research Regulatory Manager Full Description

Research Compliance Analyst

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