Clinical Research Professional
Resume:
CURRICULUM VITAE
Ed Austin, MS, BSN, CRC
Brick, NJ 08724 USA
************@*****.***
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