Research Regulatory Specialist II

Grade Level 46 | Full-Time Staff Position | Hybrid work arrangement

About the Role

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 position 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.

Responsibilities

• 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

Requirements

• Bachelor’s degree
• 2 years of related experience
• 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 skills
• Strong organization, attention to detail, time management, and ability to multi-task
• Critical thinking and problem-solving skills
• Ability to work independently and navigate institutional resources

Preferred Qualifications

• Clinical Research Certification (SOCRA, ACRP, etc.)

Skills

• Regulatory compliance for clinical trials
• IRB submissions and documentation
• Database and tracking system maintenance
• Collaboration with research teams and sponsors

Physical Requirements

• Handling of light-weight objects up to 10 pounds
• Sitting for long periods of time
• Some standing or walking
• Repetitive motion

Pay

$25.51–42.08/hour

Schedule

• Monday–Friday, 8:00 AM–4:30 PM (40 hours per week)
• Some overtime may be required

Benefits

To view our exceptional benefits, please visit https://www.uky.edu/hr/benefits.