Debra Lane Stevenson1350 Arapaho Trail Geneva, FL 32732

Office 407-388-8682FAX 407-349-9578shimasu@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 sponsor personnel in the use of EDC.Project Management Tasks:•Report to project management on status of all 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 sponsor on 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 - 2001Regional 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

SOPs. Other therapeutic areas include: pain management, weight loss, cholecystitis, diabetes type II, asthma.

COROMED, INC., Troy, New York 1999 - 1999Clinical Research AssociateHired 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 - 1999Regional Clinical Research AssociateMonitored 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 for trial 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 2000CRA (Clinical Research Associate) Training 1998PAREXEL International, Waltham, MAMaster of Arts, Health Care Administration 1997Empire State College, Saratoga, NYBachelor of Science, Human Development 1996Empire 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 Biologic GCP and Monitoring Seminar November 19, 2007 Association of Clinical Research Professionals (ACRP) Annual Convention

Phoenix, Arizona April 2006Philadelphia, Pennsylvania April 2003Toronto, Canada April 2002San Francisco, California April 2001Quintiles UniversityClinical Quality Assurance Review of Investigators January 29, 2001Time Management January 16, 2001Better Business Writing January 16, 2001Overview of the Regulatory Process and GCPs November 10, 2001Site Identification and the Clinical Quality AssuranceProcess of Clinical Investigators August 24, 2001Clinical Communications Workshop August 22, 2001CRA Mentoring Workshop July 25, 2000Electronic Records and Signatures June 6, 2000

Account Management and Business Development May 11, 2000Clinical Data Management May 7, 2000Adverse Event Workshop April 19, 2000Handling Investigational Product April 19, 2000Clinical Overview of Fraud and Misconduct April 12, 2000Drug Development Training System April 2, 2000Clinical Compliance in Action March 14, 2000Economics of Our Business March 14, 2000Sara Cannon Seminar: Lung Cancer June 10, 2003

Breast Cancer March 14, 2003Online 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 from general 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.