Silvana Summers, AAS

**** ******** ***, ********** ** 28412

Tel: 910-***-**** - email abmteq@r.postjobfree.com

education

Associate of Applied Science Degree, Microcomputer Applications, 1998

Miller-Motte Business College, Wilmington, North Carolina

Bachelor of Science, Psychology, Currently Enrolled (Online Program)

Fayetteville State University, Fayetteville, North Carolina

Professional experience

PPD, Wilmington, North Carolina

Research Coordination Manager 01 Jun 2005 -

Jun2008

Sr. Clinical Regulatory Specialist -Study Start

Up Team 16 Jun 2004

Clinical Regulatory Specialist-Study Start Up Team

20 Oct 2003

Clinical Regulatory Specialist 16

Dec 2002 Research Assistant II 01 Apr

2002

Research Assistant I 14 May

2001

. Research Coordination Manager:

Responsible for training employees, coordinate review of backlogged

transmittals for the whole Clinical Administration Team, participate as a

Guidance Management Team Member for the Clinical Administration

Leadership Program, coordinate a Phase II Study (Follicular Lymphoma).

Reconciled legal/financial information for a large Phase III study in the

primary prevention of cardiovascular events, performed review and sign

off of regulatory documents for multiple studies within Clinical

Administration Team, screened potential candidates for various

administrative positions (interviewing/providing feedback to the Sr.

Project Manager, Clinical Administration), collaborated with other

managers in a Study Start-Up Committee in order to provide

consistency/guidelines to Administrative Staff when performing Start Up

Activities for a Project.

I have been responsible for up to nine (9) Trials (Phase II and III)

simultaneously: these Trials were contracted to PPD for start up through

completion services. I have managed the operation of a clinical

administration team, coordinated the non-clinical/clinical aspects of

projects while adhering to established timelines and budgets, and

provided regulatory document technical expertise to these research trials

within the Clinical Administration Group, Wilmington Campus.

I have been responsible for supervising assigned clinical administration

personnel - up to twelve (12) direct reports -, allocating personnel

hours, coordinating clinical research management responsibilities in

accordance with the organizational goals and objectives.

Responsible for following all Equal Opportunity Employment guidelines and

Affirmative Action Plans.

Responsible for analyzing monthly research management costs, personnel

hours, and project needs to ensure the most cost effective means of

project execution while maintaining high quality standards within the

Clinical Administrative Division.

Able to supervise a diverse team and utilize talents and abilities of all

direct reports, to effectively delegate tasks and follow-up on adequate

completion, to prioritize and handle multiple tasks and studies

effectively including training and mentoring staff.

Continue to maintain excellent knowledge of proper contents of all

regulatory documents in accordance with Company's WPDs and SOPs, strong

editing skills and attention to detail, proven communication skills

including oral, written and interpersonal.

. Sr. Clinical Regulatory Specialist:

Continue to maintain all responsibilities outlined in CRS profile,

concentrating daily activities related to rapid study start up

requirements. Continue to mentor Clinical Regulatory Specialist and

Research Assistants. Continue to assist PMs, CTMs and CRAs with

regulatory related issues. Continue to collaborate with RTS to provide

feed-back related to WPDs & SOPs content to the Director of Clinical

Research Support. Cooperated with the Project Manager, Clinical

Administration, in re-generating/design an RTMS report in Microsoft

Excel: this report is currently provided to Clinical Operations team

members as a daily update for all studies awarded to PPD Start Up group

that are not currently scheduled to be entered in Siebel Clinical System.

Increased knowledge of Company's SOPs and WPDs. Continue to perform UPS

Administrator activities.

. Clinical Regulatory Specialist:

Continue to maintain all responsibilities as RAII. Increased knowledge of

close/out processes. Responsible for multiple studies within the General

Medicine Division. Interacted directly with seven (7) Research Assistants

providing training and daily mentoring. Provided support and mentoring

for other Clinical Regulatory Specialists. Reviewed and performed monthly

evaluation of up to four (4) studies within the Division. Monitored

quarterly IDS consent/background forms for the above mentioned studies,

providing feedback to Project Managers in order to keep clinical

management updated regarding active sites missing authorizations (fully

executed dates). Continue to assist PMs, CTMs and CRAs with regulatory

related issues. Collaborated with the Research Training Specialist to

provide feed-back related to WPDs & SOPs content to the Director of

Clinical Research Support. Helped to provide feedback/suggestions related

to WPDs and SOPs content and regarding the PPD Clinical Administration

Web Site. Increased knowledge of PPD SOPs and WPDs. Responsible for

creating and maintaining UPS user accounts (UPS Administrator).

. Research Assistant II:

Acquired knowledge of processes and requirements of facilitating rapid

study start up and conducting successful interim processes. Attended

Clinical and Administrative team meetings. Provided and reviewed weekly

updates. Learned to prioritize workload and identify sites that needed

immediate focus, thus ensuring rapid transmittal preparation.

Communicated appropriately study/site specific information to team

members. Assisted PMs, Associate Project Managers and Clinical Research

Associates with regulatory related issues. Successfully trained/mentored

Research Assistants II. Increased knowledge of PPD SOPs & WPDs.

Continued to mentor and assist PPD employees with computer related

questions and setbacks related to hardware and software.

. Research Assistant I:

Performed database entries for multiple studies within the General

Medicine Division with little or no error. Met demanding deadlines.

Assisted Research Coordination Manager with Investigator Payments and

entering budgets in RTMS. Created/designed different reports for the

Division to be used by RCM and Project Managers. General use of Graphic

Design and use of Microsoft Office Products. Familiarized with three (3)

different types of company software: Seagate, RTMS (Research Trial

Management System) and IDS (Investigators Database System). Served as a

mentor, trainer and troubleshooter for other users of RTMS and IDS.

Successfully assisted members of General Medicine Division with questions

related to specific computer programs such as Excel, Word, PowerPoint,

Access, Netscape and Explorer. Provided training for PPD employees

related to these computer programs. Designed tracking reports for the

Division. Effectively trained Research Assistants I. Increased knowledge

of Company's SOPs & WPDs.

Passion T.O., Inc., Wilmington, NC Manager 1997 -

2001

. Performed database entries, Graphic Design, use of Microsoft Office

Products. Expanded knowledge in Customer Service and Secretarial

activities. Managed financial transactions for the owners of the

business: Hiring, Payroll, Accounts Payable, Checking Activities, Bank

Reconciliation, End of month reports, and Inventory.

Flow Sciences, Inc., Wilmington, NC Controller Assistant

1996 - 1997

. Performed database entries, Graphic Design, use of Microsoft Office

products. Familiarized with the company software: My Product Invoice and

ACT. Assisted the Company CFO by performing activities in the following

areas: Secretarial and Customer service, Accounts Payable, Accounts

Receivable, Invoicing, Bank Reconciliation, Payroll, Checks Disbursement,

End of Month reports, End of the Year reports.

LIcenses & Certifications

. Certification for the Basic Medical Terminology with Anatomy and

Physiology, in the year 2001

. Certificates of Accomplishment: Microsoft Networking Essentials, Windows

NT 4.0 Core Technologies, Windows NT 4.0 System Administration, Windows

NT 4.0 Enterprise Technologies, Internet Information Server and TCP/IP,

in the year 2000

Professional Development

. Current on all Training specific to Company SOPs and WPDs

. Attended Siebel Clinical training since 2006

. Attended Finance Training, CAFT & CPT refresher classes since 2005

. Attended Effective Interviewing and Screening Seminar in 2004

. Attended Clinical Foundation Training (only Administrative Modules) in

2002

Prior to PPD:

July-December 2000: Completed training for Microsoft Certified System

Engineer at SoftTrain - Computer Training Centers, Wilmington, North

Carolina

Computer Experience

~ General knowledge in Hardware and Software installation

~ Experience of the following Software programs:

. Microsoft Office 97, 2000 Professional and XP

. Windows 98, 2000 and XP

. Spreadsheet and Database Applications

. Presentation Graphics and Design

. Photoshop

. Macromedia Flash MX 2004

. Microsoft NT 4.0

. Disk Operating System

. Netscape Navigator, Windows Internet Explorer, Composer, HTML and Outlook

. RTMS

. IDS

. LMS

. PASS

. Siebel Clinical System

. ClinTrack

. Cute FTP

. ACT!

. QuickBooks Accounting Software

CLINICAL TRIALS EXPERIENCE

A Phase III prospective, randomized, double-blind, placebo-controlled,

multi-center, parallel group study of intranasal Amphotericin B suspension

in patients with refractory, post-surgical CS (Chronic Sinusitis)

A Phase II, Randomized, Blinded, 12-Week Comparison Of Elvucitabine In

Combination With Efavirenz And Tenofovir Versus Lamivudine In Combination

With Efavirenz And Tenofovir In HIV-1-Infected, Treatment-Na ve Subjects,

with a 84-Week Extension Treatment Period

A Phase 2 Randomized Study Investigating The Safety, Efficacy And

Pharmacokinetics Of Daptomycin 6 Mg/Kg And 8 Mg/Kg Versus Comparator

(Vancomycin Or Teicoplanin) In The Treatment Of Subjects Undergoing

Surgical Standard Of Care For Osteomyelitis Associated With An Infected

Prosthetic Hip Or Knee Joint Caused by Methicillin Resistant Staphylococcus

Aureus And/Or Coagulase-Negative Staphylococci

A randomized, controlled, open-label trial to compare the efficacy, safety

and tolerability of TMC114/RTV versus LPV/RTV in treatment-experienced HIV-

1 infected subjects.

A Phase III randomized, double-blinded, placebo-controlled trial to

investigate the efficacy, tolerability and safety of TMC 125 as part of an

ART including TMC 114/RTV and an investigator-selected OBR in HIV-1

infected subjects with limited to no treatment options.

An open-label trial of TMC125 in HIV-1 infected subjects who were

randomized in any sponsor selected TMC125 trial to an active control arm

and either virologically failed or completed the entire treatment period,

or to a placebo arm and were treated for at least 48 weeks.

A Phase III randomized, double-blinded, placebo-controlled trial to

investigate the efficacy, tolerability and safety of TMC 125 as part of an

ART including TMC 114/RTV and an investigator-selected OBR in HIV-1

infected subjects with limited to no treatment options.

~ Substudy to evaluate the pharmacokinetic profile of TMC 125, TMC 114 and

RTV at Week 4 and 24, coadministered with an individually optimized

antiretroviral therapy.

A randomized, controlled, partially blinded Phase IIb dose-finding trial of

TMC125 in HIV-1 infected subjects with documented genotypic evidence of

resistance to currently available NNRTIs and with at least three primary PI

mutations.

An open-label trial with TMC125 in HIV-1 infected subjects, who were

randomized to a TMC125 treatment arm in a sponsor-selected TMC125 trial and

were treated for at least 48 weeks

A Randomized, Double-Blind, Placebo Controlled Trial of the Effect of

Weekly Azithromycin on The Incidence of Coronary Artery Disease in Subjects

With Evidence of Exposure to C. Pneumoniae

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-

Center Trial Of Pregabalin Versus Placebo In The Treatment Of Neuropathic

Pain Associated With HIV Neuropathy

An Open-Label, Extension Safety And Efficacy Trial Of Pregabalin In

Subjects With Neuropathic Pain Associated With HIV Neuropathy

A Multicenter, Nonrandomized, Open-Label Phase 1 Safety Study of HspE7 and

Poly-ICLC Administered Concomitantly in Cervical Intraepithelial Neoplasia

(CIN) Subjects

A Phase II Randomized, Double-Blind, Placebo-Controlled Study of the

Clinical Effectiveness of a Human Monoclonal Antibody to Clostridium

difficile Toxin A (GS-CDA1) and a Human Monoclonal Antibody to Clostridium

difficile Toxin B (MDX-1388) in Patients being Treated for Clostridium

difficile Associated Disease

A Prospective, Double-Blind, Randomized Trial To Demonstrate Equivalent

Immunogenicity Of CAIV-T And Flumist In Healthy Participants Ages 5 Through

49 Years

A Randomized, Double-Blind, Parallel Group, Multi-Center Study Of EDP - 420

Versus Telithromycin For The Treatment Of Community Acquired Pneumonia

A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase III

Study of Rosuvastatin (Crestor ) 20 mg in the Primary Prevention of

Cardiovascular Events Among Subjects with Low Levels of LDL-Cholesterol and

Elevated Levels of C-Reactive Protein

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter

Study to Determine the Safety and Efficacy of Natalizumab in Subjects with

Relapsing-Remitting Multiple Sclerosis

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter

Study To Determine The Safety And Efficacy Of Natalizumab, When Added To

Avonex (Interferon Beta-1a), In Subjects With Relapsing-Remitting Multiple

Sclerosis

A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to

Evaluate The Safety, Tolerability, And Pharmacokinetics Of Oral Pyridorin(

(PYRIDOXAMINE DIHYDROCHLORIDE) In Type1 Diabetic Patients With Diabetes-

Associated-Nephropathy

A Randomized, Double-Blind, Placebo-Controlled, Multicenter, 52-Week Study

to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of

Oral PyridorinTM (Pyridoxamine Dihydrochloride) in Patients with Type 1

Diabetes and Diabetes-Associated Nephropathy

A Double-Blind, Randomized Comparison Study of the Long Term Safety and

Efficacy of Pioglitazone HCl or Glyburide In Subjects Recently Diagnosed

with Type 2 Diabetes

A Double-Blind, Randomized Comparison Study of the Safety and Efficacy of

the Addition of Pioglitazone HCl or Placebo in Reducing or Eliminating

Insulin Requirement in Subjects Controlled on Insulin and Metformin or

Insulin Alone Who Have Previously Failed Combination Oral Therapy

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Rangin

Study of Orally Administered Recombinant Human Interleukin-11 (rhIL-11) for

the Treatment of Patients With Active Crohn's Disease

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Dose-

Ranging Study of Orally Administered Recombinant Human Interleukin-11 (rhIL-

11) in Patients With Mild to Moderate Ulcerative Colitis

A Phase II/III, Randomized, Double-Blind, Parallel-Group, Placebo-

Controlled, Multicenter Study to Evaluate the Safety and Efficacy of

Rituximab (MabThera /Rituxan ) in Adults with Primary Progressive Multiple

Sclerosis

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase IIb Study

to Evaluate the Efficacy and Safety of Multiple Alvimopan Dosage Regimens

for the Treatment of Opioid-Induced Bowel Dysfunction in Subjects with

Chronic Pain of Non-Malignant Origin

A double-blind, placebo-controlled study exploring the safety,

tolerability, and pharmacodynamic effect of INCB003284 in centrally obese

subjects with insulin resistance

A Double-Blind, Randomized, Parallel Group Clinical Trial to Compare the

Efficacy, Safety, and Tolerability of Metformin ER (M-ER) Tablets and

Metformin Immediate Release (M-IR) Tablets in the Treatment of Type 2

Diabetes Mellitus

An Open-Label Extension with Metformin ER: Double-Blind, Randomized,

Parallel Group Clinical Trial to Compare the Efficacy, Safety, and

Tolerability of Metformin Extended Release (M-ER) Tablets and Metformin

Immediate Release (M-IR) Tablets in the Treatment of Type 2 Diabetes

Mellitus

A Phase II, multicenter, randomized, double-blind, placebo-controlled,

parallel-arm, dose comparison study of the efficacy and safety of the oral

formulation of OPC-6535 tablets in the treatment of patients with mild to

moderate, active ulcerative colitis

Oncology: A Randomized Multicenter Phase III Study of

Taxane/Carboplatin/Cetuximab versus Taxane/Carboplatin as First-Line

Treatment for Patients with Advanced/Metastatic Non-Small Cell Lung Cancer

A Randomized Multicenter Phase II Study of Gemcitabine/Platinum/Cetuximab

versus Gemcitabine/Platinum as First-Line Treatment for Patients with

Advanced/Metastatic Non-Small Cell Lung Cancer

A Phase 2 Study of VELCADE (bortezomib) in Combination with Bendamustine

and Rituximab in Subjects with Relapsed or Refractory, Follicular Lymphoma

Languages

Proficient in Italian, general knowledge in speaking and reading French

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