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Mary E. Enama, M.A., PA-C
Mary Enama joined the Vaccine Research Center in January
2002. Her role is as Protocol Specialist and as Project
Officer for data management support for the Clinical
Trials Core. Her responsibilities include developing
clinical trials protocol documents in collaboration
with study teams, ensuring that the human subjects protection,
regulatory and scientific review processes are completed
before and throughout conduct of the studies, and advising
on the clinical data collection and reporting plans
needed for protocol-specified analyses and safety monitoring.
Ms. Enama notes that, “Vaccine clinical
trials are team efforts, requiring the broad range of
expertise provided by laboratory scientists, clinicians,
statisticians, pharmacists, regulatory and support staff.
It is a unique and rewarding opportunity to work with
the dedicated staff of the Clinical Trials Core to perform
the initial clinical evaluation of novel vaccine constructs
developed by the VRC such as multiclade HIV vaccines
and Ebola virus, SARS and West Nile virus vaccines.”
Prior to joining the VRC, Ms. Enama had nearly 10 years
of experience related to clinical research with a contract
research organization. During this time she worked on
clinical research-related contracts with the Division
of AIDS of the National Institute of Allergy and Infectious
Diseases and with the Investigational Drug Branch and
Regulatory Affairs Branch of the Cancer Therapy Evaluation
Program of the National Cancer Institute. Her work included
writing clinical trial protocols, preparation and maintenance
of Investigational New Drug applications, adverse event
data collection and reporting, clinical site protocol
training, and assisting with the review and reporting
of clinical trial results.
Ms. Enama was educated first as a field biologist and
laboratory scientist, earning a B.A. in Environmental
Studies at Franklin and Marshall College and M.A. in
Biology at Washington University in St. Louis. She later
earned a B.S. from the Physician Assistant program at
Medical College of Georgia and worked as a clinician
in Family Practice and Pediatric Nephrology before specializing
in clinical trials research. |