Natalie i. White ** Maple avenue
Irvington, NJ **111
**************@***.***
Clinical Research Associate
Accomplished clinical research professional skilled with experience in
monitoring a variety of site locations, performing clinical site evaluation
in varying trial stages. Performed interim and close out monitoring visits
in accordance with GCP and protocol SOP's while ensuring the validity and
integrity of study data. Adept reviewer of source documentation, including
regulatory documentation, electronic case report forms (eCRFs), participant
rosters, informed consent forms, patient study materials, and reports of
adverse events (AEs). Collaborative team player, acting as a key resource
to colleagues and health professionals.
Core Competencies
. Clinical Research Ethics
. Good Clinical Practice (GCP)
. Health Insurance Portability & Accountability Act (
HIPAA)
. Site Monitoring
Professional Experience
HealthPort Waukesha, WI . 1/2012 -3/2013
ROI Research Specialist
Responsible for processing all requests for information and documentation
release in a timely and efficient manner. Provides customers with the
highest level of customer service and quality product.
hampton KLARKE Wausau, WI . 03/2009 - 12/2011
Clinical Research Associate
Reviewed trial protocols and project SOPs as a clinical research associate
with global provider of clinical trail services. Monitored study site
activity, performed study site staff trainings and assited in TMF filing of
training records. Ensured study site documentation and adverse event
reporting were reported to CRO in a timely manner and aligned with
procedures defined within the established protocol guidelines. Assisted
global provider, hospitals and clinical sites with data collection.
Verified data on eCRFs; prepared study documentation and correspondence for
TMF filing and archiving.
Bay research Lake Geneva, WI .02/2007 -02/2009
Clinical Research Coordinator
Responsible for information tracking and inventory of clinical study
materials and supplies. Maintained and reviewed study site logs and
documents for completeness. Ensured scheduled patient visits were
maintained throughout clinical studies.
Sigma Aldrich Milwaukee, WI 53108 . 02/2006 - 01/2007
Chemist
Served as a primary chemist in environmental testing. HPLC, GC, Ph,
%Solids, Hexane Chromium. Maintained lab in accordance with GMP standards
and performed Quality control testing of final product.
atlantic health SYSTEM Summit, NJ . 1/2002 -01/2006
Administrative Assistant/ Patient Registrar
Scheduled and registered patients for various radiological procedures;
along with answering a ten- line phone system.
Education
Bachelor of Science in Biology, 2002 . Montclair State University - Upper
Montclair, NJ