Provide vendor oversight support for start-up, conduct, and close-out activities for Phase II-IV interventional and registry studies; assigned to nine protocols within oncology, immunology and CNS. Review, adjudicate and approve ICF revisions submitted by sites to ensure language is in accordance with ICH/GCP guidelines, and legal and contract affiliate group requirements. Track site activation status and activities; maintain tracker to assess timelines for contract, budget and IRB approvals, and SIV schedules to report to study management teams. Perform review and approval of essential study site documents in accordance with local regulatory requirements, SOPs and ICH/GCP guidelines.Generate and review upper management reports from internal tracking systems at requested intervals to ensure data quality and adherence to study timelines.Report weekly study recruitment/enrollment and site activation metrics to study management; participate in management discussions regarding tactics in subject accrual and maintenance. Liaise with leaders in affiliate groups such as data management, biostatistics, safety, and medical teams to ensure study specific plans and/or processes are conducted within study plans, timeline and budget.

Primary coordinator for a Sponsor-initiated, multi-center Phase IB immunotherapy study in 20 solid tumor types; currently with 10 active and over 160 pre-screening subjects on study.Obtain informed consent for pre-screening patients and ensure study procedures are implemented while adhering to study protocol and according to Good Clinical Practice and local IRB standards.Interact with study Principal and Sub-Investigators to provide efficient communication of current study status, slot availability, protocol revisions/amendments, and required site trainings.Initiate, maintain, and review electronic and paper based Trial Master File to ensure accuracy and completeness.Report study data and resolve queries in electronic data capture systems such as InForm and OnCore; and manage routine Sponsor data/regulatory monitoring visits. Assist in the training of new staff in the Early Phase Unit; help troubleshoot any unforeseen study-related complications and serve as a resource and backup coordinator on various Phase I trials.

Managed pre-clinical efficacy and pharmacokinetic/pharmacodynamic studies at national and international contract research organizations (CROs) to support the Translational Oncology group. Served as a liaison between CROs, team members, and scientists; to draft study protocols, facilitate study initiation, monitor and present study progress, and close-out terminated studies. Served as primary point of contact for one CRO:Genentech collaboration to resolve any unforeseen study-related complications, manage study timelines, and oversee completion of studies.Conducted data analysis and documented study timelines with project management and in-house software programs: AtTask, DIVOS, and LASAR.

Investigated anti-CD20-TLR9 agonist antibody drug conjugates in a syngeneic immunocompetent model for B cell non-Hodgkin’s lymphoma under the mentorship of Dr. John M. Timmerman.Characterized direct effects of conjugates in vitro by assessing proliferation, complement-dependent cytotoxicity, antibody-dependent cell-mediated cytotoxicity, cell surface marker expression by flow cytometry, and sub-cellular localization by confocal microscopy.Delineated in vivo effects of conjugates in human CD20-expressing animals by assessing normal B cell depleting efficacy, and overall survival rate compared to unconjugated single agents.

Received the “Recognition of Outstanding Teaching” award from the department of Microbiology, Immunology, and Molecular Genetics for the 2012 school year.Assisted professors for upper-division Immunology courses.

Assisted professors for upper-division Immunology courses.

Managed ordering and inventory of lab supplies, supervised lab safety in accordance with State and University regulations, and trained research personnel of standard operating procedures.

Examined therapeutic effects of flavo​noids on human pancreatic cancer cell lines by assessing intracellular signaling pathways and in vivo efficacy in an orthotopic xenograph model. Authored abstracts and presented at regional meetings and national conferences, such as the American Pancreatic Association and American Association for Cancer Research.