Clinical Trial Compliance Administrator

University of Kentucky; Lexington (KY); Hybrid; USD 70,000 - 90,000; Full time

Job summary

The University of Kentucky’s Clinical Research Support Office (CRSO) seeks a dedicated Clinical Trial Compliance Administrator to oversee registration and reporting on ClinicalTrials.gov and ensure alignment with FDA, NIH, ICMJE, and CMS requirements.

You will write and maintain SOPs, develop investigator training, and coordinate with OPSA, ORI, and Corporate Compliance to sustain robust regulatory compliance across studies.

Qualifications

• Experience in clinical research with regulatory compliance.
• Experience with ClinicalTrials.gov and registry reporting.

Responsibilities

• Administer the University of Kentucky’s ClinicalTrials.gov program, including registration and reporting.
• Write, implement, and maintain SOPs and university policies related to CT.gov operations.
• Develop training programs for investigators and provide one-on-one support for investigator-initiated trials.
• Prepare reports to ensure ongoing compliance and update institutional leadership.
• Coordinate the CT.gov program with related offices (OPSA, ORI, Corporate Compliance).

Skills

Clinical Research

Regulatory compliance

Data analysis

Communication

Tools

ClinicalTrials.gov

CTMS

Job description

Click here for more information about equivalencies:

Required License/Registration/Certification

None

Physical Requirements

sitting for long periods of time; repetitive motion related to computer use

Shift

Fully remote
Monday-Friday, 8:00 am-5:00 pm EST

Job Summary

Internal Employee Being Considered

Shape the Future of Clinical Research Administration at the University of Kentucky

Wildcat Wisdom, Kentucky Innovation – Supporting Discoveries, Transforming Outcomes!

Why Join Us?

The University of Kentucky’s Clinical Research Support Office ( CRSO ) is seeking a dedicated and skilled Clinical Trial Compliance Administrator. This vital role supports and enables groundbreaking clinical research across the University.

About the Role:

This position is eligible to be fully remote.

The position serves as an education and compliance expert regarding federal regulations governing ClinicalTrials.gov. ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world. Clinical research trials must be registered and reported in the publicly accessible database as required by Food and Drug Administration, National Institutes of Health, International Committee of Medical Journal Editors, and the Centers for Medicare and Medicaid Services. This position will administer the University of Kentucky’s ClinicalTrials.gov program, including registration and reporting. The position is responsible for writing, implementing, and maintaining Standard Operating Procedures and University policies, developing training programs for investigators, providing one‑on‑one assistance for investigator‑initiated trials, preparing reports to ensure compliance and to keep institutional leadership updated, and coordinating the program with other compliance offices including Office of Sponsored Projects Administration, Office of Research Integrity, and Office of Corporate Compliance. The University of Kentucky uses equivalencies in determining if a potential applicant meets the minimum education and experience. Related experience can be substituted for education. Click here for more information about equivalencies: https://hr.uky.edu/employment/working-uk/equivalencies

Why Clinical Research Professionals Choose University of Kentucky

• Top 10% of Academic Medical Centers Nationwide: Recognized as a leader in research excellence and innovation.
• Forbes’ Best Large Employers: Ranked among the Top 100 Employers Nationwide in 2024 and named one of Kentucky’s Best Employers on Forbes’ America’s Best-In-State Employers list.
• 1 of 34 Universities Nationwide: Holds the prestigious trifecta of research designations in cancer, aging, and translational science.
• Flexible Remote Work Options: Enjoy the convenience of fully remote or hybrid roles while supporting groundbreaking research.
• Professional Development Opportunities: Engage in interdisciplinary collaborations, virtual conferences, and training programs to advance your career.

Want to learn more about the Department?

The Clinical Research Support Office ( CRSO ) provides support to investigators and study teams conducting clinical research, including clinical trials. Services provided by the CRSO include maintaining a clinical trial management system ( CTMS ), conducting coverage analysis, developing study budgets, negotiating payment terms with sponsors, and regulatory services. More information can be found at: https://research.uky.edu/clinical-research-support-office .

Interested in what UK Benefits have to offer?

The University of Kentucky is proud to offer a benefits package that helps us recruit and retain the very best faculty and staff. In addition to your take‑home pay, your benefits package is a major component of your total compensation at UK. These benefits include our 200 percent match on eligible retirement contributions; competitive health, dental, and vision coverage; tuition benefits for classes at UK, and much more. To learn more about these exceptional benefits, please visit: https://hr.uky.edu/employment/exceptional-benefits-for-university-of-kentucky-staff .

Skills / Knowledge / Abilities

Significant Clinical Research background in health related, research, or clinical field required. Ability to communicate for effective relationships; ability to establish working relationships across a variety of departments, centers, and administrative offices; current and relevant experience with analysis and reporting of data, preferably related to clinical trials; knowledge of University policies and procedures and federal regulations

Does this position have supervisory responsibilities?

No

Preferred Education/Experience

Deadline to Apply

Deadline to Apply 09/30/2026

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 previous work experience with the clincaltrials.gov website (PRS system). (Open Ended Question)
• * Please describe your experience with regulatory compliance as it relates to the CT.gov site and maintenance of the records. (Open Ended Question)