Registered Nurse Management

DEBRA M. STEPHENSON, RN, Sr. CCRA

Stephenson Consulting Services, Inc.

* *** ****

Clarksville, VA 23927

(an hour from Raleigh/RTP, NC)

Office/Cell 919-***-****

Fax 614-***-****

*******@***.***

EDUCATION

1977 - 1980

Registered Nurse Degree, Watts Professional School of Nursing, Durham, NC

PROFESSIONAL EXPERIENCE

I have had the opportunity to work on Phase I-IV Pharmaceutical and Device

trials; performing all types of Monitoring Visits: Site Credentialing, Pre-

Site Selection (PSVs/PSSVs), Site Initiation (SIVs), Interim Monitoring

(IMVs) and Close-Outs (COVs); providing me with experience with the

following:

. Basic Site Monitoring/Management Duties have included:

> high degree of detail and accuracy

> ensuring Investigator/site adherence to the CFR and ICH/GCP

Guidelines, appropriate SOPs and Protocols

> evaluating overall site performance

> ensuring adequate regulatory compliance

> reviewing Investigator and site staff responsibilities

> site education regarding Protocol and CRF completion

> CRF/Source Documentation Verification (SDV)

> Investigational Product accountability/inventory/storage/return.

. worked with sites involved in Fraud and Scientific Misconduct, resulting

in cessation of enrollment and site closure

. worked closely with non-compliant sites to bring them back into

compliance

. worked closely with sites to ensure adequate CRF and source document

availability for frequent CEC and DSMB reviews

. strong understanding of multi-therapeutic Medical Terminology, Physiology

and Pathophysiology

. professional, highly organized, produce high quality work, work

independently or as part of a team and possess excellent writing, verbal

communication, interpersonal and diplomacy skills.

. mentored/trained more junior CRAs

. mentored/trained research na ve investigative sites

I have assisted with Lead CRA duties on various multi-therapeutic studies,

as follows:

. reviewed Protocols and CRFs; identified and recommended

amendments/revisions, as needed

. been a strong study resource for other study members

. assisted with interim analysis and final database locks

. participated in the development, implementation and maintenance of:

> Monitoring Plans

> monitoring tools

> study manuals including all study forms and logs,

> ICFs

> CRFs, CRF revisions and CRF completion guidelines,

> source templates

> drug/device manuals including accountability and destruction logs

. developed and prepared training slide presentations with hand-outs and

assisted in the preparation for and presented at Investigator Meetings

. managed the clinical monitoring activities of the study and assured site

compliance with study protocols and GCP

. ensured adherence to Sponsor procedures and applicable SOPs

. oversaw monitoring activities to ensure performance was in accordance

with ICH-GCP, applicable regulations and Study Monitoring Plan

. served as a secondary point of contact for sites during primary CRA

absence

. proactively prevented and identified issues related to the trial,

including study processes, monitoring and/or site issues and communicated

with sponsor accordingly

. developed clinical monitoring strategies to ensure study timelines and

deliverables were met

. escalated non-compliance to LCRA and Project Managers

. oversaw site start-up activities, including site selection and regulatory

document collection, review, approval and tracking.

. provided CRA and site guidance and instructions, as needed

. mentored/trained and co-monitored with more junior CRAs

. mentored/trained research na ve investigative sites

. created and distributed meeting minutes

. communicated project specific information to/from trial sites and CRAs

through Q&A Logs and provided Newsletter information updates

. assisted in preparation of IRB submissions for sites using Central IRBs

. worked with management to assure investigator payments were paid in a

timely manner

. delegated tasks to Clinical Trail Assistants

. conducted Quality Control visits of other CRAs

. assisted with the monitoring of difficult sites

. worked closely with data management to ensure low query rate and

prevent/resolve data trends/problems.

In addition, I have also performed:

. Extensive SWAT Team work

. Site Audits for FDA Audit Readiness with 100% remediation to assist with

Corporate and Clinical Corrective Action Plan Agreement (CAPA)

. Database Audit

. Sponsor Trial Master File (TMF) Audit

. Investigator Site GCP Compliance Audit w/ In-depth Audit of prior SDV

practices of Sponsor and CRO

Computer Skills: Word, Excel, PowerPoint and Adobe Acrobat, Outlook, Lotus

Notes, ePharmaSolutions (ePS) for Web Portal Trail Management, IV/IWRS via

Perceptive/ClinPhone, Clinical Trial Management Systems (CTMS)

EDC Experience: eTrials, Medidata Rave and Inform 4.6, iDataFax

WORK HISTORY

These responsibilities above have been demonstrated in the studies listed

below:

March 2000 - Present: Sr. CCRA/Auditor; Independent Consultant

Myrexis, Inc. (3/17/11 - Present)

. Phase II, A Phase 2 Study of XXXXX with Radiation Therapy and

Temozolomide in Subjects Newly Diagnosed with Glioblastoma Multiforme

- iDataFax v.4.0.2 EDC, CTMS, PSVs, SIVs & IMVs

Micell Technologies, Inc. / Fidelis BioPharm (4/12/11 - 8/12/11)

. A First-In-Human Trail of a New Novel DES (XXXXX) With Sirolimus and a

Bioabsorbable Polymer for the Treatment of Patients with De Novo

Lesions in the Native Coronary Arteries - InForm 4.6 EDC, In-house

Sr. CRA duties including but not limited to: reviewing & revising

SOPs, protocols, presentations, monitoring plans, manual of

operations, ICFs, etc., site management of clinical study sites,

management and overall tracking of Adverse Events and Protocol

Deviations, payments to core labs, core lab activity, monitoring

schedules/reports, data entry & device inventory/accountability, as

well as ensuring company compliance with all Federal, State, local and

company regulations, policies and procedures.

Montreal Heart Institute Coordinating Center / Hoffmann-La Roche (8/24/09 -

12/8/10)

. Phase III, Multicenter, randomized, double-blind, parallel group,

placebo-controlled Cardiovascular Outcomes Study to Evaluate the

Potential of XXXXX to Reduce Cardiovascular Risk in Patients with a

Recent Acute Coronary Syndrome (ACS) Event and Type 2 Diabetes

Mellitus (T2D) - Site Identification/Site Selection Process, ePS,

Perceptive IV/IWRS, Inform 4.6 EDC, PSVs (via phone & visits), SIVs,

IMVs & COV

Brandt Research Consulting, LLC / Dainippon Sumitoma Pharma America

(2/22/10 - 5/3/10)

. Phase 1, Open-Label Study To Determine The Effect of Calories And Fat

Content On The Pharmacokinetics Of Repeated Dose Lurasidone 120 MG In

Subjects With Schizophrenia, Schizoaffective Disorder, Or

Schizophreniform Disorder - Investigator Site GCP Compliance Audit and

in-depth audit of prior SDV practices of sponsor and CRO

Veritude / Boston Scientific Neuromodulation (6/09/08 - 7/20/09)

. Device Trial; bion An Implantable Microstimulator for the Chronic

Treatment of Refractory Urinary Urgency Frequency Syndrome (CRB-002) -

Site Audits for FDA Audit Readiness with 100% remediation to assist

with Corporate and Clinical CAPA

. Device Trial; bion An Implantable Microstimulator for the Chronic

Treatment of Refractory Urinary Urge Incontinence Syndrome (CRB-001) -

Site Audits for FDA Audit Readiness with 100% remediation to assist

with Corporate and Clinical CAPA

. Device Trial; PRISM: Occipital Nerve Stimulation (ONS) for Migraine -

Site Audits for FDA Audit Readiness with 100% remediation to assist

with Corporate and Clinical CAPA

Feabhas, Inc. / Duramed Research, Inc. (10/09/06 - 07/08)

. A Randomized, Multicenter, Double-Blind Parallel Group Study to

Evaluate the Efficacy and Safety of Two Doses of XXXXX Verses Placebo

in Women with Overactive Bladder - PSSVs, SIVs

. Adeno Virus Study - Database Audit of selected datapoints

. A Randomized, Multi-Center, Double-Blind Exploration Study to Evaluate

the Efficacy of an Extended Cycle Combination Oral Contraceptive,

XXXXX, Which Utilizes Ethinyl Estradiol During the Usual Hormone-Free

Interval, Compared to Placebo For the Treatment of Cyclic Pelvic Pain

in Adolescents - IMVs, COV

. A Phase II, Prospective, Multi-Center, Double-Blinded, Randomized

Study to Evaluate Bleeding Patterns in Women Using One of Three

Different Ascending EE Dose Extended Cycle (91-Day) Oral Contraceptive

Regimens (XXXXX) Compared to Seasonale Oral Contraceptive Regimen -

SIVs, IMVs, COVs

Clinical Resource Network / Bard Peripheral Vascular / BBA (03/06 - 01/07)

. Device Trial; The XXXXX Carotid Revascularization Trial for High Risk

Patients with Extracranial Carotid Artery Stenosis using the Bard

XXXXX Carotid Stent and Emboshield BareWire Rapid Exchange Embolic

Protection System - PSSVs, SIVs, IMVs

Brandt Research Consulting, LLC / Sumitomo (11/05 - 12/05)

. Study Using XXXXX to Treat Schizophrenia - Trial Master File Audit

(24-site Site Regulatory Files)

SRG Woolf Group / Bostwick Laboratories (10/05 - 11/05)

. Study Using XXXXX to Treat Prostate Cancer - Database Audit

Boston Biomedical Associate, LLC (BBA) / Micro Therapeutics, Inc., Berlin

Heart, Medinol & Bard Peripheral Vascular (07/05 - 4/06)

. Device Trial; A Multi-Center, Prospective, Randomized, Controlled

Study Involving Patients Diagnosed With Ruptured or Unruptured

Intracranial Aneurysms; to Demonstrate the Safety and Efficacy of the

MTI XXXXX Aneurysm System as Compared to the Guglielmi Detachable Coil

- in-depth review of Site Data/Source; (08/05 - 09/05)

. Device Trial; Compassionate Use Trial using a Berlin Heart Pediatric

XXXXX Device as a Bridge to Heart Transplant - Data Collection (08/05

- 11/05)

. Device Trial; A Multi-Center, Prospective, Non-Randomized Clinical

Study, With a Lead-In and Pivotal Phase, to Evaluate the Safety and

Efficacy of XXXXX Carotid Stent in the Treatment of High-Risk Surgical

and Non-Surgical Symptomatic and Asymptomatic Patients With Disease in

the Common Carotid Artery (CCA) and/or in the Internal Carotid Artery

(ICA) With or Without Involvement of the Bifurcation - SQVs; 10/05 -

2/06 when study delayed until undetermined date, per Sponsor

. Device Trial; A Prospective, Multi-Center, Non-Randomized Trial to

Evaluate the Safety and Efficacy of the Bard XXXXX Carotid Stent and

XXXXX Embolic Protection System in the Treatment of Extracranial

Carotid Artery Stenosis in Patients at High Risk for Carotid

Endarterectomy - Site Credentialing Assistance (10/05 - 04/06)

Clinical Resource Network / DCRI / Ortho Biotech (03/05 - 09/05) - 50% DSMB

Stopped Study & Contractors Released

. Correction of Hemoglobin and Outcomes in Renal Insufficiency; Phase IV

- IMVs, COVs

Clinical Resource Network / DOV Pharmaceutical, Inc./CATO Research (11/04 -

05/05) 50% - Start-Up/Enrollment extremely slow

. A Multi-Center, Standard of Care-Controlled Study to Evaluate the Long-

Term Safety of XXXXX for the Treatment of Chronic Low Back Pain; Phase

III - PSSVs, SIVs, IMVs

Clinical Resource Network / DCRI / Novartis (11/04 - 03/05) - 3+ Mo.

Contract

. Multinational, Multicenter, Double-blind, Randomized, Placebo

Controlled, Parallel Group Study Assessing the Efficacy of Intravenous

XXXXX XXXX in Preventing Subsequent Osteoporotic Fractures After a Hip

Fracture; Phase III - IMVs, COVs

Clinical Resource Network / SpineCore/Stryker Spine / Boston Biomedical

Associates/M2 Associates (05/04 - 01/05) 100% - 6 Mo. + 3 Mo. Contract

. Device Trial; XXXXX Intervertebral Disc Indicated for the Treatment of

Discogenic Pain Associated with Degenerative Disc Disease - IMVs (Re-

Monitoring)

Clinical Resource Network / V.I. Technologies (03/04 - 07/04) 50% - Start-

Up/Enrollment extremely slow

. A Randomized, Double Blind, Multi-Center, Phase III Clinical Trial in

Re-do Cardiac Surgery Patients, Using XXXXX and Standard Red Blood

Cell Units (Control) - PSSVs, SIVs, IMVs

Medical Device Consultants, Inc. (02/04 - 07/04) 50% - 6 Mo. Contract

. Device Trial; Stryker Howmedica Osteonics - Device Trial: A

Prospective, Randomized, Multi-Center Investigation of the Safety and

Efficacy of the XXXXX Cervical Device - IMVs, COVs

. Medtronics - x 4 related Device Trials:

> Device Trial; A Controlled Phase II Evaluation of the Safety and

Efficacy of the XXXXX Prosthesis System in the Treatment of

Abdominal Aortic Aneurysms compared to Open Surgical Repair - IMVs

> Device Trial; A Phase III Evaluation of the Safety and Efficacy of

the XXXXX Graft System in the Treatment of Abdominal Aortic

Aneurysms - IMVs

> Device Trial; A Controlled Phase II Evaluation of the Safety and

Efficacy of the XXXXX Aorto-Uni-Iliac (AUI) Stent Graft System in

the Treatment of Abdominal Aortic Aneurysms Compared to Open

Surgical Repair - IMVs

> Device Trial; A Controlled Phase II Evaluation of the Safety and

Efficacy of the XXXXX Stent Graft in the Treatment of Descending

Thoracic Aortic Aneurysms - IMVs

Monitor For Hire / ICON Clinical Research / Chitogenics, Inc. (07/03 -

02/04) - 6+ Mo. Contract

. Device Trial; Class III: Safety and Efficacy Study of XXXXX When Used

for Reduction of Postoperative Adhesion Development in Women

Undergoing Laparoscopy - PSSV, assistance/training during surgical

implants, IMVs, COVs and assistance with development and

implementation of study manual including all study forms and logs, CRF

completion guidelines and device manual including accountability and

destruction logs

Monitor For Hire / Omnicare Clinical Research / Adolor Corporation (11/01 -

01/04)

. Multi-center Phase III, Double-Blind, Placebo-Controlled, Parallel

Study in Opioid-Induced Postoperative Bowel Dysfunction/Postoperative

Ileus in Subjects Undergoing Total Abdominal Simple Hysterectomy -

PSSVs, SIVs, IMVs, COVs; Protocol/CRF/ICF revision development

. Multi-center Phase III, Double-Blind, Placebo-Controlled, Parallel

Study in Opioid-Induced Postoperative Bowel Dysfunction/Postoperative

Ileus - PSSVs, SIVs, IMVs, COVs; Protocol/CRF/ICF revision

development

Kern McNeil/Ingenix Pharm. Services / Abbott Laboratories (3/00 - 11/03)

. Phase III for Chronic Plaque Psoriasis - PSSVs

. Phase III International Anti-TNF Trial of Patients with Rheumatoid

Arthritis and Receiving Methotrexate - PSSVs, SIVs, IMVs;

Protocol/CRF/ICF revision development

June 1998 - March 2000: CRA; CRO Employee

Quintiles Cardiovascular Therapeutics, RTP, NC / Hoffmann La-Roche /

Hoffmann La-Roche / Hemisphere Pharmaceuticals

. Phase III International Acute Coronary Syndrome trial - SIVs, IMVs,

COVs

. Phase II Post Acute Coronary Syndromes - SIVs, IMVs, COVs

. Phase III Unstable Angina/non-Q Wave MI trial - SIVs, IMVs with

detection of fraud/scientific misconduct, COVs

. Phase III Oral Heparin following Total Hip Replacement to prevent

DVT trial - PSSVs, SIVs

Background Prior to Clinical Research

1991 - 1998 RN, Examination Management Services, Inc. (EMSI), Raleigh,

NC

Paramedical Physical Examinations, Phlebotomy (venipuncture/fingersticks),

Personal & Medical Histories, EKGs, Long Term Care Examinations &

Interviews, Urine, Hair and Saliva Specimen Collections

1994 - 1995 RN, EMSI, Norfolk, VA

Paramedical Physical Examinations, Phlebotomy (venipuncture/fingersticks),

Personal & Medical Histories, EKGs, Long Term Care Examinations &

Interviews, Urine, Hair and Saliva Specimen Collections

1994 - 1995 RN, South Hill Community Hospital, South Hill, VA

Assessment/Implementation of patients' total physical & emotional needs,

Development & Implementation of patients' care plans, Evaluation &

Reassessment of patients' care plans, CPR Certification, IV Certification

(Insertions & Med. Administration), Preparation & Administration of all

Medications

Team Leader & Charge Nurse duties - Supervising 30 - 40 patients & up to

(5) nursing personnel, Total Patient Care

1988 - 1993 RN, Duke University Medical Center, Durham, NC

Cardio-Thoracic Surgery: Adults & Pediatrics; All Scrub & Circulating Nurse

duties; Team Management & Charge Nurse Duties - (5) O.R. Suites & (16)

nursing personnel; CABGs, Valve Replacements, Heart/Lung Transplants,

LVADs, Congenital Anomalies, Pacemakers, Aneurysm Grafts/Stent Grafts;

Wrote several Policy & Procedure Manuals for new Pediatric Procedures;

Developed, Implemented and Evaluated new policies, procedures and equipment

for newly developed pediatric procedures; planned and implemented Extra-

Corpeal Membrane Oxygenation or ECMO Program's policy and procedures for

the OR; Advanced R.N. Promotion; Computer program course

1985 - 1987 RN, Health Force Home Health Care, Raleigh, NC

Total Home Health Care for Adults and Pediatrics; Foley Catheters, Sterile

Dressings, Wound Care, IV's; Excellent Management & Organizational Skills

1985 - 1987 Real Estate Agent, Century 21, Raleigh, NC

1980 - 1985 RN, Duke University Medical Center, Durham, NC

Cardio - Thoracic Surgery: Adults & Pediatrics; All Scrub & Circulating

Nurse duties; Team Management & Charge Nurse Duties - (5) O.R. Suites &

(16) nursing personnel; CABGs, Valve Replacements, Heart/Lung Transplants,

LVADs, Congenital Anomalies, Pacemakers, Aneurysm Grafts/Stent Grafts

Orthopedics x 1 year: All Scrub & Circulating Nurse duties; Total Hips,

Total Knees, Digit Joint Replacements, Total Backs with and without Neuro

involvement, Laminectomies and Discectomies.

General, General Pediatrics & Plastics - All Scrub & Circulating Nurse

duties; limited, for reliefs & emergencies only.

LICENSES NC RN License 072147 - inactive since moved to VA

VA RN License 000*******

CERTIFICATION ACRP CRA Certification (CCRA) as of 9/15/2005

REFERENCES Available Upon Request

Revised: August 2011

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