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.
• Ultra-sensitive multiplex qPCR
• Cell culture
• Cell isolation
• RNA/DNA extraction
• DNA precipitation

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.

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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