Department Name: 40610:CTR FOR CLINICAL TRANSLATIONAL SCIENCES
The Center for Clinical and Translational Science is looking to recruit for a Regulatory Associate to join our team. The Clinical Research Associate II-Regulatory accepts research responsibility with guidance from the Principal Investigator(s) and the Regulatory Program Directory. The CRA II-Regulatory is responsible for obtaining and coordinating data and other required information needed to fulfill all the regulatory requirements for protocols, including IRB and IBC 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 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, legal) work together in the management of Clinical Research studies and protocols. CRA II-Regulatory will be required to attain certification as a clinical research professional via an accredited body (e.g. Society of Clinical Research Associates (SOCRA) or Association of Clinical Research Professionals (ACRP). CRA II-Regulatory will be required to maintain this certification by completing the necessary continuing education requirements established by the accrediting body.
Position Time Status: Full-Time
Required Related Experience:
Required License/Registration/Certification :
SoCRA or ACRP Certified
Preferred background in clinical research. Working Knowledge of Institutional Review Board Guidelines, FDA Code of Federal Regulations, and International Conference on Harmonization/Good Clinical Practice Guidelines (ICHGCP). Master's degree and experience in University of Kentucky Healthcare system preferred.
University Community of Inclusion:
The University of Kentucky is committed to a diverse and inclusive workforce by ensuring all our students, faculty, and staff work in an environment of openness and acceptance. We strive to foster a community where people of all backgrounds, identities, and perspectives can feel secure and welcome. We also value the well-being of each of our employees and are dedicated to creating a healthy place 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.
As an Equal Opportunity Employer, we strongly encourage veterans, individuals with disabilities, women, and all minorities to consider our employment opportunities.
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.
Adjacent to downtown Lexington, UK is nestled in the scenic heart of the beautiful Bluegrass Region of Kentucky. UK's campus covers more than 814 acres, with more than 30,700 students and 13,500 full-time employees, including nearly 2,400 full-time faculty and librarians.