Wanda St. Clair

acc1ka@r.postjobfree.com

Morrisville, NC

252-***-****

OVERVIEW

Specialized in the management of documentation relative to pharmaceutical development and

testing, clinical studies in support of FDA drug applications, and medical device biocompatibility

testing. Familiar with the application of HIPAA, FDA, GMP, GLP, GCP, and ICH regulatory

guidelines, as well as ISOs 10993 and 17025.

SKILLS

Medical terminology Pharmaceutical research and development

Research documentation Pharmaceutical clinical research regulatory

documentation

Clinical study data / SAS

Abbreviated New Drug Applications (ANDA)

Clinicaltrials.gov registrations

Electronic health record queries and templates

ELARA eTMF (electronic trial master file)

Health systems information technology and

RighTrack II clinical database system

networking

GDMS (Global Document Management

MS Outlook, Office Word, Excel, Access, &

System)

PowerPoint

Internet and Citrix applications

CATI - Computer assisted telephone

Health data information exchange standards

interviewing

Collecting and organizing scientific data

Data graphing and statistical analysis

WORK HISTORY

Becton-Dickinson / Axelon Services, RTP, NC, 03/2013 - Present

Preclinical Project Coordinator

Receive, process, and manage medical device samples in a corporate group performing

biocompatibility and chemical testing as required by FDA

Coordinate testing activities and ensure all project phases are documented appropriately

Collaborate with technical managers to develop testing plans according to specified requirements

and industry standards

Produce technical reports based on protocols, company policies, and FDA, GCP, and ICH

regulatory guidelines

Monitor study progress and provide client support throughout project lifecycle

RTI International / HR Directions, Raleigh, NC, 05/2012 - 10/2012

Federal Contractor - NPSAS Project

Contacted sample members of federally sponsored research study for the purposes of introducing

participants to the study, answering questions about the study, and gaining consent

Conducted study member interviews using computer applications (CATI) and web-based surveys

Recorded contact communications and relevant data in electronic system

Complied with appropriate QA/QC and confidentiality standards

Independent Contractor / LiveOps, Knightdale, NC, 07/2011 – 03/2013

Customer Service Representative

Assisted customers wishing to make inquiries or place orders for products and services

advertised by marketing partners

Provided effective and timely resolution of a range of customer inquiries

Ensured that calls were processed in strict adherence to established policies, procedures, and

quality standards, as well as any federal laws and regulations

PharmaNet Resource Solutions, Princeton, NJ, 05/2010 - 12/2010

Clinical Research Regulatory Associate – Pfizer eTMF Project

Performed checks on clinical regulatory documents within electronic trial master files (eTMF) to

ensure compliance with applicable regulatory requirements

Ensured that eTMF contained appropriate regulatory documentation based on protocols,

company policies, and FDA, GCP, and ICH regulatory guidelines

Corresponded with study personnel for retrieval of outstanding documents and resolution of

compliance issues

Sandoz Inc., Wilson, NC, 11/2006 - 08/2009

Clinical Study Coordinator (for Pharmaceutical Sponsor)

Coordinated clinical study schedules and product development timelines

Managed project meetings to identify, analyze, and define project scope, requirements, and

deliverables

Study protocol review and approval

Calculated test sample requirements and shipped clinical supplies to study sites

Performed quality reviews of regulatory documentation, research data, and study reports.

Ensured regulatory binders contained all essential documentation for trial master files according

to appropriate regulatory guidelines

Corresponded with study personnel for retrieval of outstanding documents and resolution of

compliance issues

Prepared final clinical study documentation packages for ANDA submissions to FDA

Created and maintained project database

Compiled research projects status reports

Collaborated in the development of SOPs relative to clinical study operations

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Sandoz Inc. (formerly Eon Labs), Wilson, NC, 06/2005 - 11/2006

Research Laboratory Notebook Auditor

Audited research scientists’ formulation notebooks and data generated during drug product

development and analytical testing

Reviewed pilot batch production records

Ensured documented processes complied with set guidelines of SOP/GLP/GMP

Extracted raw laboratory data for inclusion into research procedural methods, method validation,

and drug product certificate of analysis (CofA)

Performed graphical analysis of research laboratory data

West Teleservices, Hampton, VA, 12/2003 - 03/2005

At Home Agent

Received inbound calls from customers wishing to make inquiries or place orders for products

and services advertised by marketing partners

Provided effective and timely resolution of a range of customer inquiries

Ensured that calls are processed in strict adherence to established policies, procedures, and

quality standards, as well as any federal laws and regulations

Sentara Healthcare, Norfolk, VA, 07/2002 - 10/2003

ER Administrative Associate

Collected patient demographic and insurance information for hospital registrations

Provided HIPAA information and financial counseling

Received copayments and prepared daily deposits of department's collections

Organized and maintained departmental files and patient outcome logs

Compiled and reported daily health statistics for ambulatory emergency room visits

EDUCATION

Public Health

Walden University - Minneapolis, MN, (Master in Public Health capstone project in progress)

Health Information Technology (H.I.T.) Implementation Support Specialist

Central Piedmont Community College - Charlotte, NC 07/2012

Bachelor of Science, Biology

Old Dominion University - Norfolk, VA, 12/2000

Associate of Science, Science

Thomas Nelson Community College - Hampton, VA, 05/1998

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