Research Regulatory Specialist II

Edtech.com's Summary

The University of Kentucky is hiring a Research Regulatory Specialist II to support the Markey Cancer Center's clinical trials program. The role involves coordinating regulatory activities for oncology clinical research, ensuring compliance with institutional, federal, and sponsor requirements, and serving as a resource for investigators and research teams.

Highlights

Prepare and submit IRB applications, amendments, continuing reviews, and other regulatory materials.
Maintain complete, accurate, and audit-ready regulatory documentation for clinical research projects.
Coordinate reports, correspondence, and submissions for regulatory agencies and institutional review boards.
Interpret and apply regulatory, institutional, and policy requirements to clinical research protocols.
Monitor IRB, HIPAA, responsible conduct of research, and human-subjects protection training for research personnel.
Maintain internal databases and tracking systems for research projects, deadlines, and approvals.
Assist with administrative and financial activities associated with clinical trials.
Collaborate with investigators, clinical research staff, sponsors, and institutional partners.
Required knowledge includes Good Clinical Practice (GCP), NIH and FDA regulations, and effective communication skills.
Qualifications: Bachelor's degree, two years of related experience; Clinical Research Certification preferred.
Compensation ranges from $25.51 to $42.08 per hour.
Position supports the University of Kentucky Markey Cancer Center clinical research organization.

Research Regulatory Specialist II Full Description

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Posting Details

Job Title	Research Regulatory Specialist II
Requisition Number	RE55508
Working Title	RRS II
Department Name	7H024:MCC - CLINICAL RESEARCH ORG
Work Location	Lexington, KY
Grade Level	46
Salary Range	$25.51-42.08/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 University of Kentucky Markey Cancer Center—Kentucky’s only National Cancer Institute-designated Comprehensive Cancer Center—is seeking a Research Regulatory Specialist II to support our growing clinical trials program. This aposition plays an essential role in ensuring that oncology clinical research is conducted efficiently and in accordance with institutional, federal, and sponsor requirements. The Research Regulatory Specialist II will coordinate regulatory activities for clinical trials and serve as a knowledgeable resource for investigators and research teams. Key responsibilities include: * Preparing and submitting initial IRB applications, amendments, continuing reviews, and other regulatory materials to the University of Kentucky and collaborating cancer centers * Maintaining complete, accurate, and audit-ready regulatory documentation for assigned clinical research projects * Coordinating reports, correspondence, and required submissions for regulatory agencies and institutional review boards * Interpreting and applying regulatory, institutional, and policy requirements to clinical research protocols * Monitoring required IRB, HIPAA, responsible conduct of research, and human-subjects protection training for research personnel * Coordinating and documenting safety review meetings, as needed * Maintaining internal databases and tracking systems for research projects, deadlines, approvals, and periodic renewals * Organizing regulatory files and supporting inspection and audit readiness * Assisting with select administrative and financial activities associated with clinical trials * Collaborating with investigators, clinical research staff, sponsors, and institutional partners to keep studies moving forward The ideal candidate is highly organized, detail-oriented, and comfortable managing multiple priorities and deadlines. This is an excellent opportunity for someone who enjoys collaborative work, problem-solving, and contributing to research that advances cancer care for patients across Kentucky and beyond. 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. Clinical Research Certification (SOCRA, ACRP, etc.) preferred.
Deadline to Apply	09/10/2026
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 (*).

* Describe your experience working in an administrative role, or with data entry/data management duties.
(Open Ended Question)

Applicant Documents

Required Documents

Resume
Curriculum Vita

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

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

Posting Details

Job Title	Research Regulatory Specialist II
Requisition Number	RE55508
Working Title	RRS II
Department Name	7H024:MCC - CLINICAL RESEARCH ORG
Work Location	Lexington, KY
Grade Level	46
Salary Range	$25.51-42.08/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 University of Kentucky Markey Cancer Center—Kentucky’s only National Cancer Institute-designated Comprehensive Cancer Center—is seeking a Research Regulatory Specialist II to support our growing clinical trials program. This aposition plays an essential role in ensuring that oncology clinical research is conducted efficiently and in accordance with institutional, federal, and sponsor requirements. The Research Regulatory Specialist II will coordinate regulatory activities for clinical trials and serve as a knowledgeable resource for investigators and research teams. Key responsibilities include: * Preparing and submitting initial IRB applications, amendments, continuing reviews, and other regulatory materials to the University of Kentucky and collaborating cancer centers * Maintaining complete, accurate, and audit-ready regulatory documentation for assigned clinical research projects * Coordinating reports, correspondence, and required submissions for regulatory agencies and institutional review boards * Interpreting and applying regulatory, institutional, and policy requirements to clinical research protocols * Monitoring required IRB, HIPAA, responsible conduct of research, and human-subjects protection training for research personnel * Coordinating and documenting safety review meetings, as needed * Maintaining internal databases and tracking systems for research projects, deadlines, approvals, and periodic renewals * Organizing regulatory files and supporting inspection and audit readiness * Assisting with select administrative and financial activities associated with clinical trials * Collaborating with investigators, clinical research staff, sponsors, and institutional partners to keep studies moving forward The ideal candidate is highly organized, detail-oriented, and comfortable managing multiple priorities and deadlines. This is an excellent opportunity for someone who enjoys collaborative work, problem-solving, and contributing to research that advances cancer care for patients across Kentucky and beyond. 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. Clinical Research Certification (SOCRA, ACRP, etc.) preferred.
Deadline to Apply	09/10/2026
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 (*).

* Describe your experience working in an administrative role, or with data entry/data management duties.
(Open Ended Question)

Applicant Documents

Required Documents

Resume
Curriculum Vita

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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.

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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