Research Regulatory Specialist II in Lexington, Kentucky at University of Kentucky

2 yrs

None

Requires handling of light-weight objects up to 10 pounds, sitting for long periods of time, some standing or walking, repetitive motion.

Monday-Friday, 8:00am-4:30pm (40hrs wk), Some overtime may be required.

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.

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.

Bachelor’s degree and at least 2 years of related experience. Clinical Research Certification (SOCRA, ACRP, etc.) preferred.

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.