Lily Ugor

Senior Clinical Research Associate

IQVIA

Nov 2021 - Current (4 years 10 months)

Independently monitor Phase I–IV clinical trials across multiple therapeutic areas, ensuring regulatory compliance and data integrity. Oversee site qualification, initiation, routine monitoring, and closeout visits for 10+ global sites. Generate timely and comprehensive monitoring reports and submit follow-up letters in compliance with sponsor timelines. Performed PSSVs, SIVs, IMVs, COVs respectfully. Identify, report, and follow up on protocol deviations, ensuring documentation and resolution. Conduct source data verification and ensure the accuracy of data in EDC systems such as Medidata Rave and Veeva. Facilitate training and mentorship of junior CRAs and serve as point-of-contact for operational troubleshooting. Collaborate cross-functi

In-House CRA

Kite Pharma

Jan 2019 - Nov 2021 (2 years 11 months)

Monitored subject safety remotely and verified compliance with informed consent regulations through site communications and documentation review. Reviewed electronic case report forms (eCRFs) for completeness, accuracy, and consistency with source data, supporting data validation efforts. Collaborated with investigators and site staff remotely to resolve data queries and discrepancies in a timely manner. Assisted in preparing sites for interim and final audits by ensuring all documentation and regulatory requirements were met. Supported site qualification, initiation, monitoring, and close-out activities (PSSVs, SIVs, IMVS, COVs) through remote coordination and document review. Maintained and updated tracking systems for essential documents

Clinical Research Associate II

Kite Pharma

Nov 2016 - Jan 2019 (2 years 3 months)

Ensured adherence to protocol requirements, regulatory standards, and Good Clinical Practice (GCP) guidelines throughout the lifecycle of clinical trials. Conducted various types of site visits, including Pre-Study Site Visits (PSSVs), Site Initiation Visits (SIVs), Interim Monitoring Visits (IMVs), Close-Out Visits (COVs), and Remote Monitoring, to assess protocol compliance, data quality, and participant safety. Led site initiation, monitoring, and closeout visits to evaluate protocol compliance, data integrity, and participant safety. Coordinated study start-up activities, including site selection, regulatory submissions, and contract negotiation, to facilitate timely initiation of clinical trials. Provided training and mentorship to jun

Clinical Research Associate I

PPD

Jan 2014 - Nov 2016 (2 years 11 months)

Conducted feasibility assessments and site selection visits in alignment with study protocols. Managed operational aspects of site activities, including patient recruitment and retention. Performed PSSVs, SIVs, IMVs, COVs respectfully. Ensured compliance with study protocols, ICH-GCP, and regulatory requirements. Provided training and ongoing support to site staff and investigators. Ensured timely collection and resolution of data queries and monitoring issues. Managed site budgets and ensured alignment with project financial forecasts. Oversaw IP management, including storage, dispensation, and reconciliation. Addressed and documented protocol deviations and implemented corrective actions. Maintained high site performance through relations

Clinical Trial Assistant

PPD

Nov 2012 - Jan 2014 (1 year 3 months)

Supported the clinical operations team by maintaining and organizing trial documentation in the Trial Master File (TMF). Assisted in the preparation and tracking of study-related documents, including site initiation packages and regulatory submissions. Coordinated meeting logistics, took minutes, and followed up on action items for internal and external clinical trial meetings. Communicated with clinical research sites to collect essential documents and resolve administrative issues. Monitored timelines and maintained tracking systems to ensure compliance with regulatory and study requirements.

M

Clinical Research Coordinator

MD Anderson Cancer Centre

Jan 2011 - Nov 2012 (1 year 11 months)

Coordinated daily clinical trial activities for early-phase oncology studies. Managed subject screening, consent, enrolment, and follow-up per protocol. Prepared source documentation and entered data into EDC systems. Scheduled patient visits and maintained compliance with visit windows. Collected, processed, and shipped lab samples per protocol and IATA guidelines. Reported adverse events and assisted PI with SAE documentation. Ensured compliance with IRB approvals, consents, and amendments. Assisted in the development of study tools and patient tracking logs. Maintained accurate and timely data entry and performed query resolution. Coordinated with pharmacy and labs for investigational product handling. Participated in site audits and add

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