jessica daly

* Conducts investigator and clinic staff GCP trainings. * Provides weekly updates for all studies to both sponsor and site. * Advises principal investigators on reporting of adverse events, serious adverse events, and deviations according to IRB and GCP guidance. * Develops work instructions for site as needed, including procedures for adverse event collection, research lab draws, etc. * Reviews patient visits for protocol compliance, logging and reporting deviations as needed. * Administers informed consent (ICF) with patients and investigator. * Completes regulatory submissions to the Institutional Review Board (IRB). * Reviews patient eligibility for trial, ensuring all inclusion criteria are met and have source documentation.

* Reviewed all site CRFs for completion, issued queries as needed for further information. * Maintained patient database and patient trackers. * Produced study reports in collaboration with the statistician at the request of sponsors for phase two and phase three clinical trials. * Communicated with sites to ensure the understanding of protocol and sponsor needs. * Facilitated the RECIST read of each clinical trial; coordinating with UCLA radiologists to have thousands of scans reviewed for progression or response. * Screened hundreds of subjects through the National Lung Screening Trial (NLST) for eligibility for new trial. * Performed quantitative image analysis and RECIST evaluations on MRI and CT scans in order to measure renal cell carcinoma or prostate cancer in over 2,000 subjects worldwide.

* Manages audit findings for all internal, external and corporate audits. * Follows-up with management to resolve phases of each finding. * Strives to initiate the investigation, implementation and verification of effectiveness for corrective actions. * Monitors field corrective actions and recalls. * Analyzes complaints for reportability to the FDA. * Assists with complaint closure for national and international complaints. * Composes letters for clients in need of updates on product evaluation findings. * Accomplishments * Increased audit finding timeliness by from 48% to 86%. * Created an organized system for tracking all audit findings. * Successfully passed CAPA training test.

* Executed and supervised 12 clinical research studies at a time, from recruitment of subjects to end of study. * Coordinated schedules of patients, doctors, nurses, and specialists while adhering to strict protocol * guidelines. * Provided personalized patient care, working with patients to understand clinical trial schedule and concepts. * Coordinated studies, including screening of potential patients for protocol eligibility. * Scheduled patients for research procedures per protocol. * Documented changes in patient condition, adverse events, concomitant medication use, protocol compliance, and response to study drug in support of the physician. * Worked closely with regulatory coordinator or with the Institutional Review Board to submit Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines. * Ensured compliance with all federal and local agencies including FDA and IRB.

Activities and Societies: Alpha Chi Omega, UCLA Unicamp, Rho Lambda Honors Sorority