BS

4 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 Markey Cancer Center, Clinical Research Org. (CRO) is seeking to hire a Research Regulatory Specialist III (RRS III). The RRS III accepts research responsibility with guidance from the Principal Investigator(s) and the Research Administration and Operations Director. The RRS III 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 will have 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. 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.

Comprehensive understanding 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, collaboration, attention to detail, time management, and ability to multi-task. Work independently and navigate institutional and external resources. Critical thinking and problem solving. Ability to teach/coach and lead teams. Serves as a mentor for RRS I and II. Review and assess work for quality and compliance.

Bachelors degree and four years of related experience or UK equivalencies. Certification preferred (SOCRA, ACRP, etc.)

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.