Joey Quesenberry Email Address

Clinical Research Associate

For more than 125 years, Norton Healthcare's faith heritage has guided its mission to provide quality health care to all those it serves. Today, Norton Healthcare is the Louisville area's leading, most comprehensive health care system (45 percent market share) and third largest private employer, providing care at more than 125 locations throughout Greater Louisville and Southern Indiana. The Louisville-based not-for-profit system includes five Louisville hospitals with more than 1,800 licensed beds; five outpatient centers; 12 Norton Immediate Care Centers; 11,300 employees; more than 480 employed medical providers; and about 2,000 total physicians on its medical staff. Norton Healthcare is the 2011 recipient (and the only one in the state of Kentucky) of the prestigious National Quality Forum National Quality Healthcare Award and has consistently been recognized as one of the best places to work in Metro Louisville, the state of Kentucky and nationally. Norton Healthcare and Humana are one of only four national pilot sites, and the only one in Kentucky, to study the Accountable Care Organization (ACO) model through the prestigious Brookings - Dartmouth ACO Pilot Project.

Joey is a Clinical Research Associate since 2021 who is very detail oriented and has excellent communication skills. She has a comprehensive background, including experience in clinical research since 2016 with focus in Oncology (Phase I-IV trials) of various indications. Joey utilizes critical thinking skills and strategic organization in order to implement clinical trials. Current key responsibilities include the following: • Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines. • Work with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability. • Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues. • Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate. • Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase. • Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) verify that the Investigator's Site File (ISF) is maintained in accordance with GCP / ICH and local regulatory requirements. • Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation. • Collaborate and liaise with study team members for project execution support as appropriate. • If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis. • If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.