Leslie Kelley

Background

About Leslie Kelley

Self-motivated, detail and goal oriented Certified Clinical Research Professional (CCRP) with extensive expertise in handling regulatory and compliance matters related to human subject protection in national and international oncology clinical trials. Extensive knowledge in the cancer clinical trials process, from initial FDA submission through to IRB approval, trial monitoring and beyond. Broad based knowledge of ICH, 45CFR46 and FDA guidelines, federal and local regulatory requirements in compliance with HIPAA/IRB/FDA/GCP regulations and requirements. Extensive experience in IND/IDE submissions, annual reports submissions in addition to amendments/supplements submissions of post approval changes. Possess superior organizational, verbal communication skills, collaborative leadership skills and able to delegate work assignments. Serves as a member of an Institutional Review Board (IRB) for a regional health organization which including being the senior expedited reviewer for all clinical trial submissions. This entails evaluating the ethics of the research, assuring that subjects are fully informed of risks/benefits of the research and providing continual regulatory oversight of the research projects. Additionally, act as the resource person for guidelines and requirements of clinical trials pertaining to all studies submitted to the Institutional Review Board (IRB).