Remote Clinical Trials Compliance Specialist

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

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.