Research Regulatory Specialist II

Research Regulatory Specialist II at University of Kentucky Research Regulatory Specialist II at University of Kentucky in Lexington, Kentucky Posted in 1 day ago.

Job Description:

University of Kentucky Equal Employment Opportunity/M/F/disability/protected veteran status. Posting Details Posting Details Job Title Research Regulatory Specialist II Requisition Number RE53237 Working Title RRS II - Reg Department Name 7H024:

MCC - CLINICAL RESEARCH ORG

Work Location Lexington, KY Grade Level 46 Salary Range $25.01-41.25/hour Type of Position Staff Position Time Status Full-Time Required Education BS Click here for more information about 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 (40 hours per week). Some overtime may be required. Job Summary The Markey Cancer Center, Clinical Research Organization, is recruiting for a Research Regulatory Specialist II (RRS II - Regulatory). This position accepts research responsibility with guidance from the Principal Investigator(s) and the Research Admin & Operations Director. The RRS II-Regulatory is responsible for obtaining and coordinating data and other required information needed to fulfill all the regulatory requirements for protocols, including IRB submissions, informed consents, safety reports, and adverse event forms. Maintain all regulatory records as per FDA regulations. Maintain trial management databases required for each protocol. Ensure accuracy and completeness of regulatory records and verify ongoing studies are completed in accordance with applicable FDA regulations. Will participate in site evaluation, initiation, monitoring and termination visits. Develop standard operating procedures for regulatory activities to improve compliance and efficiency. Will assist in protocol development. The individual in this position will be expected to have an understanding of how the different areas of specialization (regulatory, IRB, financial) work together in the management of clinical research studies and protocols. 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. Research certification (SOCRA, ACRP, etc.) preferred. Deadline to Apply 05/20/2026 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 (•). • Please select the answer that best describes your years of paid, full-time employment experience in clinical research. None More than 0 years, up through 1 year More than 1 year, up through 3 years More than 3 years, up through 7 years More than 7 years, up through 10 years More than 10 years • Please choose the answer that best describes your years of paid, full-time employment experience working with protocol submissions, IRB's, and patient consents. None 1 - 3 years 3 - 5 years Over 5 years Applicant Documents Required Documents Resume Cover Letter Optional Documents Equal employment opportunity, including veterans and individuals with disabilities.

PI284401222

Salary:

$25.00