Experience

Chinook Therapeutics, a Novartis Company

• United States
• Biotechnology Research
• 100 - 200 Employee

• Senior Regulatory Affairs Associate

  • Jul 2023 - Present

  San Diego, California, United States

• Regulatory Affairs Associate

  • Dec 2021 - Jul 2023

  San Diego, California, United States



University of Nebraska Medical Center

• Higher Education
• 700 & Above Employee

• Regulatory Coordinator II

  • Nov 2019 - Dec 2021

  Omaha, Nebraska, United States • Served as the lead regulatory coordinator for the Adaptive COVID-19 Treatment Trial (ACTT) under the lead PI and as the primary regulatory contact for all sites under the Special Pathogens Research Network (SPRN) utilizing the UNMC Single IRB • Responsible for the regulatory conduct and oversight for 25+ trials in oncology, cardiology, neurology, infectious diseases, and gastroenterology • Implemented and validated a university-wide 21 CFR Part 11 compliant electronic signature system… Show more • Served as the lead regulatory coordinator for the Adaptive COVID-19 Treatment Trial (ACTT) under the lead PI and as the primary regulatory contact for all sites under the Special Pathogens Research Network (SPRN) utilizing the UNMC Single IRB • Responsible for the regulatory conduct and oversight for 25+ trials in oncology, cardiology, neurology, infectious diseases, and gastroenterology • Implemented and validated a university-wide 21 CFR Part 11 compliant electronic signature system (Advarra eReg) Show less



Rainier Therapeutics

• United States
• Pharmaceutical Manufacturing

• Sr. Clinical Research Associate

  • Dec 2017 - Oct 2019

  San Leandro • Maintain oversight and management of US research sites participating in a global Urothelial Cell Carcinoma trial, “FIERCE-22” • Key resource and point of escalation for research institutions conducting the FIERCE-22 study • Support clinical trial sites by writing and reviewing informed consent forms, 1572’s, financial disclosure forms, and other site regulatory documents • Submit study protocol and trial documents to central IRB’s on behalf of trial sites • Maintain Global… Show more • Maintain oversight and management of US research sites participating in a global Urothelial Cell Carcinoma trial, “FIERCE-22” • Key resource and point of escalation for research institutions conducting the FIERCE-22 study • Support clinical trial sites by writing and reviewing informed consent forms, 1572’s, financial disclosure forms, and other site regulatory documents • Submit study protocol and trial documents to central IRB’s on behalf of trial sites • Maintain Global, country, and site level Informed Consent Forms for submission to Ethics Committees and Institutional Review Boards by a Contract Research Organization or site regulatory staff • Perform routine on-site monitoring oversight visits to ensure ICH/GCP compliance, data quality and integrity • Track study progress towards approved study endpoints to support data presentations and FDA meetings Show less



Dynavax Technologies

• United States
• Biotechnology Research
• 200 - 300 Employee

• Clinical Research Associate I

  • Feb 2017 - Nov 2017

  Berkeley CA I oversaw oncology trials in Metastatic Melanoma and Head and Neck Squamous Cell Carcinoma as well as Lymphoma. My duties included sample and lab kit management as well as site management through start up.

• Clinical Trial Assistant

  • Oct 2015 - Jan 2017

  I am currently working as a Clinical Trial Assistant for two early phase cancer immunotherapy trials. I previously worked on a multicenter pivotal phase 3 trial and supported the clinical team submit a BLA application. I manage routine study activities such as: tracking and maintaining controlled documents, reviewing documents for accuracy and completeness, organizing study team meetings, writing detailed meeting minutes, and assisting with the development, maintenance, and distribution of… Show more I am currently working as a Clinical Trial Assistant for two early phase cancer immunotherapy trials. I previously worked on a multicenter pivotal phase 3 trial and supported the clinical team submit a BLA application. I manage routine study activities such as: tracking and maintaining controlled documents, reviewing documents for accuracy and completeness, organizing study team meetings, writing detailed meeting minutes, and assisting with the development, maintenance, and distribution of study documents. I assisted the company to prepare for a BLA submission by partaking in pre-inspection activities and thorough quality control checks of essential documents.

• Clinical Operations Intern

  • Jul 2015 - Sep 2015

  Assisted each facet of Clinical Operations including Early phase trial management, Late phase trial management, Medical writing, and Clinical document control for Hepatitis B Vaccine (HEPLISAV), Lymphoma and Melanoma (SD-101), and Asthma (AZD1419). Projects include: Trial Master File Quality Control check (HEPLISAV) Off-site storage of past clinical study (HEPLISAV) TMF audit of flagship drug trial (HEPLISAV) IVRS data reconciliation and CSR amendments for past studies… Show more Assisted each facet of Clinical Operations including Early phase trial management, Late phase trial management, Medical writing, and Clinical document control for Hepatitis B Vaccine (HEPLISAV), Lymphoma and Melanoma (SD-101), and Asthma (AZD1419). Projects include: Trial Master File Quality Control check (HEPLISAV) Off-site storage of past clinical study (HEPLISAV) TMF audit of flagship drug trial (HEPLISAV) IVRS data reconciliation and CSR amendments for past studies (HEPLISAV) Wrote and produced source documents for early phase Melanoma study’s eCRF (SD-101)



University of California, Santa Cruz

• United States
• Higher Education
• 700 & Above Employee

• Undergraduate Researcher

  • Sep 2013 - Jun 2015

  Chen Lab Studied the role of a cortical transcription factor and its regulation of subcerebral projection neurons. I gained proficiency in tissue collection/analysis, PCR, immunofluorescence microscopy, as well as a strong foundation in more basic laboratory procedures.

• Teaching Assistant

  • Sep 2014 - Dec 2014

  MCD Graduate Division I was hired as an undergraduate to work alongside graduate students as a teaching assistant for an upper-division cell biology course. I graded over 250 student’s exams and led discussion sections twice a week.



SRI

• United States
• Research Services
• 700 & Above Employee

• Student Associate

  • Jun 2012 - Sep 2013

  Menlo Park, Ca Studied neurotransmitter expression levels through HPLC analysis, successfully performed EEG/EMG transmitter implantation surgeries, gained experience with microdialysis probe insertion via stereotaxic surgery, conducted sleep deprivation experiments, Cerebral Spinal Fluid (CSF) collection via microdialysis for HPLC, and sectioned tissue for histology analysis



University of California, Santa Cruz

• United States
• Higher Education
• 700 & Above Employee

• Undergraduate Researcher

  • Oct 2012 - Jun 2013

  Saxton Lab I studied mitochondrial dynamics in Drosophila axons while utilizing confocal microscopy and worked concurrently as a laboratory technician preparing solutions.