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  1. I Am ORA

I Am ORA Profile: Zerita White

Zerita White, Consumer Safety Officer, ORA/FDA Division of Bioresearch Monitoring Operations II (DBIMOII) West

Zerita White, Consumer Safety Officer, ORA/FDA OBIMOW Division II

I am U.S. Public Health Service Commissioned Corps Officer Lt. Commander Zerita White, a consumer safety officer (CSO) in the FDA Office of Regulatory Affairs, Division of Bioresearch Monitoring II (West), Investigations Branch.

In my position as a CSO, I work with our internal FDA partners to enforce the laws and regulations protecting consumers. I inspect clinical trial data for new drugs, devices, and biologics to ensure the integrity of the data that has been submitted to FDA and those data can be relied upon to make an application decision.

I want the public to know that the COVID-19 vaccines authorized by FDA for emergency use are safe and effective.

I have worked in the private sector as a registered nurse since 1995. I was introduced to the U.S. Public Health Service Commissioned Corps after five years of service in the United States Air Force. I was inspired by the Commissioned Corps and its commitment to “protect, promote, and advance the health and safety of our nation.” As a nurse and member of the Commissioned Corps, I have increased my opportunity to positively impact my community and public health.

In Fall 2021, I was deployed to Honolulu, Hawaii to support and increase the nursing personnel at a large metropolitan hospital. I was initially bombarded with information regarding COVID-19 treatments, efficacy, and the varied symptoms and effects of the virus. I was able to see, firsthand, how COVID-19 impacted my individual patients. I used my skill and expertise in the nursing field coupled with empathy, a sense of global community, and the desire to directly affect public health to support patients and the nursing staff while deployed in Hawaii.

In my day-to-day role, I conduct inspections of clinical investigators, institutional review boards, and sponsors. A significant part of my job is to work with other agency partners including FDA’s Center for Biologics and Evaluation Research (CBER) that regulates blood, vaccines, allergenics, tissues, and cellular and gene therapies.

My primary responsibilities include conducting clinical trial inspections. I was provided a unique opportunity, and chosen to conduct an on-site inspection of the Moderna COVID-19 Vaccine protocol. As a scientist, health care provider, and public health servant, I was honored to review the scientific data as it applied to real people injected with the vaccine or placebo. I was charged with reviewing the scientific data from a clinical trial for a vaccine that has impacted the entire world. I truly feel that this experience has afforded me an incredible and direct opportunity to impact public health.

I am Zerita White, and #IAmORA.

 

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