Perform and coordinate aspects of external clinical studies including site selection, study initiation, site monitoring, and study closeout.

1. Wendy Johnson
Clinical Research Associate
Education
University of North Carolina at Greensboro
Bachelors of Science
Biology
Pfeiffer University
Masters
Health Administration
Summary
• Over 4 years of experience working in a clinical laboratory and over 8 years of experience as a
medical laboratory technologist.
• Clinical Laboratory Areas include:
Oncology
Fluorescence In-Situ Hybridization (FISH) Assay to detect breast cancer
Epidermal Growth Factor Receptor Immuohistochemical (EGFR IHC) Assay to detect colon
cancer and used in clinical trial studies
Nuclear Matrix Protein 22 ELISA Assay to detect bladder cancer
Clinical Chemistry
Isoelectric Focusing (IEF) and High Performance Liquid Chromatography (HPLC) to detect
abnormal hemoglobin disorders
Electrospray Tandem Mass Spectrometry (MS/MS) to identify abnormal disorders of the
metabolism
Molecular Biology
PCR Amplification on high IRT level patients to detect if Cystic Fibrosis mutations were present

2. Professional Experience
DOCS Global
Clinical Research Associate
January 2016-Current
Design, plan, coordinate, and conduct all activities involved in
initiating, monitoring, and completing clinical research studies for in
vitro diagnostics.
Clinical Research Associate
January 2016-Current Agent representing Roche Diagnostics, Clinical Operations
Responsibilities:
• Performing or coordinating aspects of external clinical
studies including site selection, study initiation, site
monitoring, and study close out.
• Maintaining communication with study investigators to
ensure studies are completed in a timely fashion and
ensuring that study objectives are met.
• Interfacing with other Roche staff to support post launch
activities.
• Ensuring that studies adhere to FDA regulations, Good
Clinical Practices, IVD directives, and Roche policies and
procedures.
North Carolina State
Laboratory of Public Health
Medical Laboratory
Technologist
May 2011 to December 2015
Responsible for performing genetic disorder tests (cross-trained) in
all laboratories of Newborn Screening which include:
Hemoglobinopathies, Cystic Fibrosis, and Tandem Mass
Spectrometry.
Responsibilities:
• Interpreted, analyzed, and reported accurate test results of
patients.
• Provided customer service and educational support to
healthcare providers.
• Developed and implemented activities that were indicators
and monitors of accountability in the quality assurance
program (QA program includes test methodologies,
evaluation of patient test results, personnel competence,
communications, quality assurance records review, quality
control, proficiency testing, and complaint investigations).
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3. • Increased quality improvement of receiving patient samples.
LabCorp, Inc.
Oncology Technologist
January 2008 to May 2011
LabCorp, Inc.
Specimen Laboratory
Accessioner
August 2007- December 2007
Performed various prognostic cancer testing such as lung, colon,
bladder, and primarily breast cancer patients.
Responsibilities:
• Evaluated and documented HER-2/neu signal intensity on
slides with an epifluorescence microscope for patient
records. These results helped pathologists determine
quickly if the patient was applicable for the Herceptin (breast
cancer) drug.
• Help initiated and performed clinical trials from global clients
using the Epidermal Growth Factor Receptor (EGFR)
Immunohistochemical (IHC) assay to detect cancer in the
lung and colon tissue.
Received, sorted, and accessioned blood, urine, and saliva
specimens for occupational testing.
Responsibilities:
• Regularly exceeded department sample processing goals by
working overtime as needed to meet deadlines.
• Updated database with patient information to expedite the
process time.
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