Department Name: 7H0CR: Clinical Research Support Office
The University of Kentucky Clinical Research Support Office (CRSO) provides support to investigators and study teams conducting clinical research. Recently the CRSO expanded its scope of services from clinical trials to clinical research management. This expansion includes the proper review of each clinical research study to determine: the level of management in the CTMS system, the data entry needed, the Epic participation determination, the calendar services including the financial calendars, and the ongoing technical assistance once the study is in Epic. Services provided by the CRSO include maintaining a clinical trial management system (CTMS), conducting coverage analysis, and billing review for all clinical research studies, financial management of clinical research studies in collaboration with CCTS and other partners and providing regulatory services. The CRSO is seeking qualified candidates for a Team Lead Clinical Research Administrative Support and Billing position. This position performs detailed reviews of complex study protocols, budgets, informed consent forms, contracts, FDA documents, and other relevant study documents to determine the minimum data requirements based on the CRSO approved scope of work. Determine the Epic participation based on the billing and other needs for the management of the research study, and develop the financial and clinical comprehensive calendars. Provide training to CRSO staff on various processes including data entry in the CTMS system, the minimum footprint data requirements, internal processes for both regular and financial calendars and the Epic management of subjects. The role performs its work collaboratively with investigators, study teams, clinical research coordinators, and other research staff while serving as a resource on the CTMS content as it relates to clinical research administrative support and as an integral component to maintaining proper billing integrity and compliant standards. This role will also cross-train on clinical trial budget data entry and charge review process during first tier while monitoring the initial dashboard from Epic. The ideal candidate works well independently and on teams, is organized, exercises sound judgement, and possesses attention to detail. It is preferred that candidates have a minimum of two years' work experience in a clinical research setting along with a BA/BS in a health-related discipline or equivalent professional experience.
Regulatory knowledge, medical terminology and clinical research knowledge, strong competency in Microsoft Office products (especially Word, Excel, PowerPoint).
Position Time Status: Full-Time
Required Related Experience:
Required License/Registration/Certification :
It is preferred that the candidate have work experience in clinical research with some graduate courses if possible or a related certification in Research.
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.