The Markey Cancer Center is seeking a Regulatory Coordinator who will perform activities to support central operations of a network conducting multi-center studies. Position duties are specific to overall site, study & program regulatory coordination, data & regulatory compliance.
This includes: serving as a resource to investigative teams, regulatory document management, regulatory quality, contributing to network operations, facilitating site start-up, maintaining trial master file, network membership master files, facilitating study project teams, participating in network committees, assisting Study Chairs & Project Teams to assure the conduct and oversight of quality studies, as applicable interfacing with MCC SRFs and MCCCRO.
The MCCRN Regulatory Coordinator serves as the primary liaison to sites for regulatory management, ensuring data & regulatory compliance utilizing variety of quality methods including coordination, training, monitoring. Duties require application of CFR, ICH, SOPs.
MS professional programs, research databases, HIPAA, HSP, web.
Position Time Status: Full-Time
Required Related Experience:
Required License/Registration/Certification :
Professional certification(s) in clinical research or project management: PMP – CAPM, PMP, SoCRA – CCRP, and/or ACRP – CCRC or CCRA
Bachelor’s degree with seven or more years related experience.
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.