Brenda Tran (Smithhisler) Email & Phone Number

• Prepare submissions to IRB• Manage study implementation and required approvals• Assist with study monitoring• Maintain ISFs• Facilitate regulatory oversight of safety reporting and submit reports to FDA• Train regulatory staff

• Supported and completed submissions to IRB• Managed post approval study team training• Administrative management of CTMS and eReg system• Coordinated and maintained training and delegation logs• Coordinated distribution and investigator review of third party safety reports

Aided in manufacturing, document control, and implementation of an eQMS.

Studied a breadth of biomedical regulatory affairs topics including clinical trials, product development and manufacturing, quality systems, and risk management.

Seattle, Wa

Responsible for a variety of tasks including laboratory maintenance, developing a laboratory safety training program, and assisting with writing SOPs. As the designated company point-of-contact for our eQMS, I worked to help my team understand and adopt the software.

Seattle, Wa

Worked as a team member to test and advance an ultra-sensitive HIV-1 DNA quantitative real-time PCR assay. I also researched regulatory requirements and pathways to market. I gained technical lab experience that included:• Ultra-sensitive multiplex qPCR• Cell culture• Cell isolation• RNA/DNA extraction• DNA precipitation• Reverse transcription

Tacoma, Wa

For this summer program for underrepresented youth in STEM, I co-instructed middle school students on a variety of molecular biology topics, including lab safety, lab techniques, a brief history of molecular biology, and how to present your research. In a combination of lab and lecture, we worked to identify local cases of market substitution of salmon, i.e., selling farmed fish labeled as fresh. The students proudly presented their findings in academic posters and oral presentations to both public and scientific audiences.

My goal was to help both the professor and students of a molecular biology course successfully complete lab sessions. Before the session, I would help prepare and set up materials. During the session, I would help students use equipment safely and answering student questions. And then of course, clean up!

Tacoma, Wa

Project: Larval Behavior and Ocean AcidificationUniversity of Washington Tacoma, SAFS, and the Washington State Department of Natural Resources• Developed species-specific qPCR assays for four species of bivalves.• Analyzed qPCR results and performed troubleshooting as necessary.• Collected, analyzed, and evaluated field samples using a polarized microscope and precise pipetting techniques.• Constructed DNA extraction SOPs and improved planktonic DNA isolation procedures.• Prioritized project components and organized with collaborators to meet deadlines and budget requirements.

Master Of Science - Ms, Pharmacy Administration And Pharmacy Policy And Regulatory Affairs

Biomedical Regulatory Affairs

Bachelor’S Degree, Environmental Science-Biology Track

Emt Certification

Education record

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