Debra Lane Stevenson has over 15 years of experience as a clinical research associate (CRA) working on various clinical trials. She has worked on trials related to cardiology, oncology, dermatology, and other therapeutic areas. As a CRA, her responsibilities include conducting site initiation visits, monitoring visits, and study closeout activities to ensure compliance with regulations and good clinical practices. She is proficient in electronic data capture systems and has worked with sponsors such as Allergan, Bayer, Trevena, and others.

1. Debra Lane Stevenson
1350 Arapaho Trail
Geneva, FL 32732
Office 407-388-8682
FAX 407-349-9578
shimasu@citlink.net
POSITION: Regional Consultant Clinical Research Associate
EMPLOYMENT: Self-employed contractor, Geneva, FL 2001 - Present
Contract Clinical Research Associate working with multiple organizations in the therapeutic areas of
Interventional cardiology, cardiology (surgical studies), oncology (malignant melanoma) and cardiac
Devices:
 Allergan: Dry Eye Syndrome and Wet Age Related Macular Degeneration: Nov 2015 to present
 Bayer: Prostate Cancer with Bone Metastasis: May 2015 to Dec 2015
 Trevena: Acute Cardiac Heart Failure: April 2014 to July 2016
 Celladon: Gene Therapy Cardiovascular: July 2013 to April 30, 2015
 Endologix: Renal artery stent: May 2013 to August 2015
 Pfizer: Lung Cancer, October 2012 to March 2014
 Phase Two Diuretic study in Heart Failure, May 2012 to December 2013
 Type I diabetes phase IV study: May 2012 to September 30, 2012
 Canine Diabetes Study: January 2012 to January 2013
 Genetech: Severe Asthma, March 2012 to September 30, 2012
 Endologix: Cardiac device, May 2010 to October 2012
 Corthera: Inpatient Continuous Infusion study in Heart Failure, May 2011 to September 30 2012.
 Cardioxyl Pharmaceuticals: In patient Infusion study in Decompensated Heart Failure,
February 2011 to October 2011.
 Teva Pharmaceuticals: Asthma, August 2010 to February 28, 2011
 GSK: Phase 1 Hepatic, May 2010 to July 2011
 Stiefel Laboratories: Dermatology, Phase 1 studies: January 2008 to July 2010
 Hilltop Research: Phase 1 studies: October 2009 to March 2010
 GSK: Oncology: October 2007 to June 2009
 Bioforce Solutions: Cardiac studies 2006-2008
 LaJolla Pharmaceutical Company: Lupus Nephritis 2006-2007
 Medtronics: Cardiac stent, 2005-2006
 Scios: CABG 2003-2005
 PAREXEL International: Melanoma January 2001- August 2003
CRA Tasks:
Conduct initiation, monitoring, and termination visits for up to 17 sites using electronic data capture
(EDC) throughout the trial. Trained site staff, new CRAs, and sponsorpersonnelin the use of EDC.
Project Management Tasks:
•Report to project management on status ofall outstanding items to be completed for all sites scheduled
for terminations. Maintain tracker with updates from Primary CRA and team CRAs. Provide report to
management and sponsoron weekly basis of updates and status. Document all pending items from
Termination Visits.
•Assisted with Quality Control Audit of Site Central Files (QC) to identify findings and report them to
project management.
• Liaison between site CRAs and the Primary CRA to collect all outstanding regulatory documents noted
on the QC spreadsheets.
QUINTILES, INC., Cranbury, NJ 2000 - 2001
Regional Senior Clinical Research Associate (CRA)
Hired as a Senior CRA to monitor clinical sites for several cardiology trials including Phase III Acute
Myocardial Infarction (with CABG) and Phase II Arrhythmia with ICD. Maintained 18 sites on AMI
trial located between Nebraska and New York, working with the sites from Qualification through
termination. Mentored new CRAs on various studies,reviewing their job performance per Quintiles

2. SOPs. Other therapeutic areas include: pain management, weight loss,cholecystitis, diabetes type II,
asthma.
COROMED, INC., Troy, New York 1999 - 1999
Clinical Research Associate
Hired as CRA to monitor clinical sites for a large Phase III Congestive Heart Failure (CHF) trial.
Maintained 16 sites from qualification through monitoring phases of trial.
PAREXEL INTERNATIONAL, Waltham, MA 1998 - 1999
Regional Clinical Research Associate
Monitored large multicenter Osteoporosis trial, capturing bone density measurements of women post
menopause to form a national database for further research into this disease. Identified patient
populations,presented trial information to physicians at local offices, consented patients fortrial and
retrieved data for sponsor.
Substitute Teacher, BOCES, Johnstown, and Greater Amsterdam School District 1994 - 1997
Taught English, math, science, physical education and special education classes as needed.
THERAPEUTIC AREAS: Heart Failure, Congestive Heart Failure, Acute Myocardial Infarction (with CABG), Arrhythmia,
HTN, DVT, Diabetes Type II, Osteoporosis, Pain Management (pre and post-op),Cholecystitis,
Asthma, Weight Loss, Oncology (Malignant Melanoma, Colon) and Antisense drug therapy,
Peripheral Arterial Disease, Acute Care Studies, PCI, non-emergent CABG, including surgical and
non-surgical trials, Lupus Nephritis, Acne and Seborrheic Dermatitis.
Ophthalmology: Dry Eye; Glaucoma
Pediatric: Anticoagulant use in cath lab
Phase 1 Trials: Various indications
Devices: AICD, Thoracic Stent, Abdominal Stent, Renal Artery Stent, Closure Device
SKILLS: Electronic Data Capture (RAVE, Oracle RDC, InForm, eTrials, Target)
EDUCATION: ACRP Clinical Research Associate Certification and Member 2000
CRA (Clinical Research Associate) Training 1998
PAREXEL International, Waltham, MA
Master of Arts, Health Care Administration 1997
Empire State College, Saratoga, NY
Bachelor of Science, Human Development 1996
Empire State College, Saratoga, NY
CONTINUING ED: Icon GCP Updated certification January 2014
Pfizer/Icon GCP and CRA certification November 2012
Covance GCP Training August 31, 2012
LSU Health Science Center Hemodynamic training August 10, 2011
Drug and BiologicGCP and Monitoring Seminar November 19, 2007
Association of Clinical Research Professionals (ACRP) Annual Convention
Phoenix, Arizona April 2006
Philadelphia, Pennsylvania April 2003
Toronto, Canada April 2002
San Francisco, California April 2001
Quintiles University
Clinical Quality Assurance Review of Investigators January 29, 2001
Time Management January 16, 2001
Better Business Writing January 16, 2001
Overview of the Regulatory Process and GCPs November 10, 2001
Site Identification and the Clinical Quality Assurance
Process of Clinical Investigators August 24, 2001
Clinical Communications Workshop August 22, 2001
CRA Mentoring Workshop July 25, 2000
Electronic Records and Signatures June 6, 2000

3. Account Management and Business Development May 11, 2000
Clinical Data Management May 7, 2000
Adverse Event Workshop April 19, 2000
Handling Investigational Product April 19, 2000
Clinical Overview of Fraud and Misconduct April 12, 2000
Drug Development Training System April 2, 2000
Clinical Compliance in Action March 14, 2000
Economics of Our Business March 14, 2000
Sara Cannon Seminar: Lung Cancer June 10, 2003
Breast Cancer March 14, 2003
Online Collaborative Oncology Group Seminar: Hematology March 2002
EXPERIENCE:
Study Initiation: •Conduct site selection visits to determine appropriate Investigator resources necessary for completing
successful research trials.
•Ensure completion of regulatory documents.
•Instruct Investigator and staff in protocol specifications and study management.
•Review Investigator’s 1572 responsibilities.
Study Monitoring: •Participate in phase I, II, III and IV trials in a variety of settings with Investigators ranging fromgeneral
practitioners to surgical physicians.
•Assess Investigator’s study performance and adherence to GCPs, protocol requirements and FDA
regulations.
•Maintain current site regulatory files.
•Perform source document review to ensure accuracy of CRF and eCRF data.
•Review AEs and SAEs for thoroughness and timeliness of reporting.
•Resolve data queries including using the eCRF system.
•Perform drug accountability.
•Prepare site reports and maintained regular written and telephone contact with sites.
Study Termination: •Resolve all residual site issues including retrieval of outstanding CRFs, and unused study drug, and
resolution of remaining data queries.
•Complete final site reports.
General: •Mentor new CRAs in various study functions. Provide monitoring training for new CRAs.
•Maintain strict adherence to protocol requirements, FDA regulations, ICH Guidelines, Good Clinical
Practice (GCP), and Sponsor and CRO standard operating procedures
•Involved in creation of study documents, including tracking forms, slides for presentations, etc.