Clinical Research Quality Control

Chris Delozier, MSCR

*** ****** ***** ?Kure Beach, NC 28449 ?910-***-****

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

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Summary of Qualifications

. 12 years of drug development experience including Clinical Lead and

Clinical Research Associate working on multi-center research studies

. Therapeutic area monitoring experience in Cardiology, Musculoskeletal,

Oncology, Infectious Disease, Metabolic, Neurological, Respiratory,

and Ophthalmology studies

. Advanced degree in Clinical Research

Professional Experience

Delozier Consulting, Inc.

6/2006- present

Independent Contract CRA

iCS/Curis, Duke 2/2011-

present

. Ensured compliance with clinical trial protocols, FDA regulations, and

GCP/ICH guidelines

. Performed on-site visits and site management

Quintiles/Pfizer

4/2008-12/2010

. Ensured compliance with clinical trial protocols, FDA regulations, and

GCP/ICH guidelines

. Performed on-site visits and site management

MWA/Reservlogix

3/2010-7/2010

. Managed study investigational product supply and distribution

Pharmatech/Eisai

6/2008-1/2009

. Ensured compliance with clinical trial protocols, FDA regulations, and

GCP/ICH guidelines

. Performed on-site visits and site management

i3/Gilead and Debiopharm

6/2006-4/2008

. Ensured compliance with clinical trial protocols, FDA regulations, and

GCP/ICH guidelines

. Performed on-site visits and site management

PAREXEL International Corporation, Durham, NC

2/2005- 6/2006

Senior Clinical Research Associate/Clinical Lead

. Led clinical project activities, monitoring functions, and managed

clinical supplies

. Responsible for site evaluation, initiation, data collection and

quality control review of data collected at trial site

. Ensured compliance with clinical trial protocol(s), FDA regulations

and GCP/ICH guidelines for Phase II, III, and IV trials

. Created study materials, reviewed visit reports, tracked client

deliverables

Inveresk (formerly PharmaResearch Corporation), Wilmington, NC

5/2003- 2/2005

Clinical Research Associate

. Assessed and trained research sites to participate in clinical trials

of investigational and marketed drugs

. Assured subject safety clinical trial data and accuracy,

accountability, and documentation through review of case report forms

(electronic and paper), source documents, and medical records

. Verified clinical trial compliance with GCP/ICH, FDA, and local

regulations

GlaxoSmithKline, RTP, NC 6/1999 - 5/2003

Division of Bioanalysis and Drug Metabolism

Assistant Scientist

. Provided analytical support for compounds in late discovery to full

development in accordance with GLP's including LC/MS/MS quantitative

bioanalytical method development, validation, and implementation

Chemist, RTP, NC

Magellan Laboratories

1999

Trimeris 1998 Fortron Bio Science 1997

- 1998

Laboratory Corporation 1996 - 1997

Education

Campbell University, Buies Creek, NC 2004

M.S. Clinical Research, Magna Cum Laude

North Carolina State University, Raleigh, NC 1996

B.S. Biochemistry, B.A. Chemistry

Technical Skills

Microsoft Office

Electronic Data Capture

. Oracle Clinical Remote Data Capture

. Phase Forward Inform

. Medidata Rave

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