CURRICULUM VITAE

Ed Austin, MS, BSN, CRC

Brick, NJ 08724 USA

ab50j5@r.postjobfree.com

1-848-***-****

www.linkedin.com/pub/ed-austin/49/435/823

Education:

Concord Rusam Shool of Medical Professions

Accelerated Nursing Program

New York, NY/ Moscow, Russia

Graduation/Diploma. BSN April 2011

ACRP CRC Certification Program

Clark, NJ

CRC/ICH Certification September 2010

Applied Business Management Program

Toms River, NJ October

2008

Center for Business Education and Training at

Ocean County Community College.

Certificate of Completion.

Medical Research Management Inc.

Parsippany, NJ

Fundamentals of Clinical Research

CRA: Certificate of Completion April 2007

YSMA Medical Academy,

Yaroslavl, Russian Federation.

M.S. General Medicine. July 1997

Qualifications:

Excellent record of educational and professional background ensuring

feasibility of the project, document/data management, database maintenance

and query resolution, implementation of the protocols and delivery with

high quality data. Thorough knowledge of drug development cycle, ICH

Guidelines and GCP. Unique, hands-on experience in the development,

planning, launch, conduct, closure, and submission of Phase I-IV clinical

trials in accordance with all applicable global, federal, state, local

laws/regulations and corporate policies within the US or within

international corporate environment. Medical/Clinical/ Regulatory/ Safety

expertise essential for data management, clinical conduct and SOP

development. Proven organizational, administrative and time management

skills. Intimate knowledge of regulatory environment and business settings

related to clinical trials.

Areas of Interest/Expertise: EDC (eClinica/ InForm/ PhaseForward/ Phoenix/

Oracle/ et al. ) and Data/Document Management solutions within Phase I-II /

Phase II-IV studies; Neurocognitive, AD/Dementia Cardiovascular studies,

QA/QC; IT resources; Clinical Trials: site/project initiation,

administration and performance quality monitoring.

Professional Experience:

Clinical Research Coordinator/Rater

Memory Enhancement Center of New Jersey 01/2010 to

current

Study selection and project negotiation, including site/sponsor meeting,

teleconferences, correspondence, CRF & SOP development, planning and

clinical setup of the trial, submission of documents for regulatory

approval. Document and Database Development. Clinical data review, query

resolution and reconciliation, Maintenance of key contacts with IVRS,

Central Labs, Vendors and IRB's.

Budget negotiations, review and implementation of prospective projects.

Overview of the project and introduction of the protocol to site members.

Recruitment plan, Informed Consent procedures, Management of master files

and regulatory documents.

Liaise with with clients as well as with associated clinical centers to

ensure project deliverables, milestones, subject safety, site adherence to

the protocol, to the FDA regulations and ICH/GCP guidelines during the

study conduct.

Provide clinical and scientific expertise related to study planning and

conduct, quality control and quality assurance.

Development of effective process and QC cycle, site staff training,

allocation of resources, recruitment efforts, contacts with partners, with

local communities and vendors. Maintain and ensure compliance of regulatory

documents, source documents, drug accountability; A/E reporting, quality

control and project delivery.

Clinical Research Coordinator

Iberica Clinical Research Center 04/ 2008

to 01/2010

Development, design and implementation of clinical trials phase I and II.

Assistance with study selection and project negotiation, including

site/sponsor correspondence, source document development, preparation of

protocol implementations, submission of documents for IRB approval.

Ensure subjects safety and site adherence to FDA regulations and ICH/GCP

guidelines during study conduct.

Review and implementation of study protocols, Informed Consents, SOP's, and

regulatory documents.

Provide clinical and scientific expertise related to study planning and

conduct.

Maintain and ensure accuracy of source documents, drug accountability, A/E

reporting and query resolution.

Training, support and staff in-services, data management and quality

assurance.

Clinical Conduct Associate 02/2004 to 01/2008

MDS Pharma Services Inc.

Assistance and implementation of phase I & II clinical trial procedures.

Ensured subject safety, screening, consent process, enrollment and conduct

of clinical research projects.

Maintained source documentation, data capture, reconciliation and query

resolution.

Conducted clinical operations, drug administration, sample collection,

storage, processing and shipment.

Assured adherence of site staff members to The Protocol, ICH/GSP and FDA

guidelines.

Research Experience (2004-2013)

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the

Safety, Tolerability, Pharmacodynamic and Pharmacokinetic Effects of BMS-

708163 in theTreatment of Patients with Prodromal Alzheimer's Disease.

Bristol-MyersSquibb Company.

A Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Safety

and Tolerability of Multiple Dose Regimens of CHF 5074 (200, 400, 600

mg/day for up to 12 Weeks) and to Explore the Effects on Potential Markers

of Clinical Efficacy in Patients with Mild Cognitive Impairment. Chiesi

Pharmaceuticals Inc.

A Randomized, Double-Blind, Placebo controlled, Parallel Groups, Ascending

Single-Dose Phase I Study to Evaluate the Safety, Pharmacokinetics and

Pharmacodynamics of ?-secretase modulator CHF5074 in Young Male Subjects.

Chiesi Pharmaceuticals Inc.

A Single, Blind, Placebo-Controlled, Assending oral dose study to evaluate

the Safety, Tolerability and Pharmacokinetics of OBP601.Oncolys BioPharma,

Inc.

Effect of single ingestion of Dihydrocapasiate Emulsion on Resting

Metabolic Rate(RMR) Randomized Double-blind cross-over study. Ajinomoto

USA, Inc.

Phase 2, randomized, double-blind, parallel-group, placebo-controlled study

to evaluate the effects of MABT5102A on brain amyloid burden (as assessed

by amyloid PET imaging) and other biomarkers in patients with mild to

moderate Alzheimer's disease. Genentech

Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled,

Parallel-Group Efficacy And Safety Trial Of Bapineuzumab In Subjects With

Mild To Moderate Alzheimer Disease Who Are Apolipoprotein E ?4 Non-

Carriers. Pfizer.

Phase 3 Extension, Multicenter, Double-Blind, Long-Term Safety And

Tolerability Trial Of Bapineuzumab (AAB-001, ELN115727) In Subjects With

Alzheimer Disease Who Are Apolipoprotein E e4 Noncarriers And Participated

In Study 3133K1-3000 (NCT00667810). Pfizer.

A Randomized Double-Blind, Placebo-Controlled, Parallel-Group Study to

Compare Safety/Tolerability, Pharmacokinetics and to explore

Pharmacodynamics Between Caucasian and Japanese Male subjects following

single and multiple doses of LCI699. Novartis International AG.

A Randomized,Double-Blind,Placebo-Controlled,Crossover Clinical Study of

Monosodium L-Glutamate(MSG) and Nucleic Acid (IMP) to Evaluate the Effects

on Taste and Gastrointestinal Sensation in Female Adults. Ajinomoto USA,

Inc.

A Randomized, Open Label, Clinical Study of TK-542 to Evaluate

Pharmacokinetics Following Single or Multiple Doses in Japanese Adult

Subjects. Teikoku Pharma USA, Inc.

Influence of Race/Origin on the Pharmacokinetics of Vicriviroc SCH 417690.

Schering-Plough Research.

A Randomized, Open Label, 2-way Crossover Study to Compare Bioavailability

of a Capsule Formulation of PS433540 to a Solution Formulation of PS433540.

Pharmacopeia, Inc.

A 2-way Crossover Fasting Steady State Dosage Strength Proportionality

Study of antidepressant Bupropion Hydrobromide XL

Tablets (522 mg vs. 3x174 mg) in Non-Smoking Adults. Biovail

Technologies, LTD

A Randomized, double-blind, three-way crossover study to compare the

systemic exposure of multiple inhaled doses of mometasone furoate and

indacterol when administered alone or in fixed dose combination via

Twisthaler device. Novartis International AG.

Experience with the following study tools, vendors and IRBs:

Electronic Data Capture (EDC) Institutional Review Boards (IRBs)

experience: experience:

InForm WIRB

e-Trial Schulman

Phase Forward Copernicus

Novartis EDC's Sterling

TrialLink IntegReview

DATALABS Chesapeake Research Review

Oracle Ethical Review Committee

Roche EDC

Boehringer Ingelheim EDC

eClinica

Phoenix Data Systems

IVRS experience: Central Lab experience:

ICON Quest

ICTI Quintiles

ClinPhone MDS

Quintiles Covance

Medpace Mayo Central Lab

BARC

ICON

Medpace

Additional records available upon request.

Contact this candidate