Summary

I have been involved in the medical industry since 1995. My experience includes
5 years as a medical assistant, with two of those years working in pediatric
oncology. In addition I have four years working as a study coordinator and became
a certified study coordinator through ACRP.

I have over 7 years working in Clinical Research with an additional 2 years in
clinical monitoring as a CRA II in global/multi-national studies (feasibility,
phase I, II and III) across Europe, and USA.
 
I have significant experience working in Hematology, Oncology, HIV, AIDS, AIDS
related Malignancies, Neurology (including pain trials), Pulmonology, Cardiology,
OBGYN, Internal Medicine, GI, Hepatitis C, and Pediatrics.

I have monitored a number of multi-national trials across up to 4 countries
across 7 sites, and including over 84 patients. Responsibilities have spanned the
full duration of studies, from start-up to project close-out and review.

Responsibilities are summarised below 
 
 *  Feasibilities  *  Initiation visits  *  Audits
 *  Investigator Meeting Preparation  *   *  Monitoring visits & SDV  * 
Inspections
 *  Attendance to Invest Meetings  *  Closure visits  *  Submission dossier
 *  Delivery of GCP training  's  *  Query resolution  *  Collection of
regulatory packages
 *  Submissions to Regulatory body  *  Drug accountability 
 *  Submissions to Ethic committees  *  Management of SAEs  *  Re-labelling
process
 *  Site Selection visits  *  Manage Central Clinical Files  *  Enrollment
Tracking
 *  Provide Clinical Trial Assistance  *    ˜Second Scrub  ' CRF Review  * 
Co-monitor/in-house monitor
 *  Management of IP/Study Supplies  *  Site Communication 

Education / Qualifications 
Date Place of Education Degree/Qualifications
April 2001 Merck Research Strategies for Successful Study Coordination Workshop
Nov 2000 Americas Doctor University Training in Good Clinical Practices, FDA
Regulations, and Management of Clinical Trials
1995 Clover Park Technical College Medical Assistant Technical Diploma

Employment History 
Employer/From  *  To Roles & Responsibilities
Quintiles, Inc.
Tacoma, WA
July 2007 to Present Clinical Research Associate II
 *  Provide monitoring visits and site management for a variety of protocols,
sites and therapeutic areas
 *  Administer protocol and related study training to assigned sites and
establish regular lines of communication with sites to manage ongoing project
expectations and issues
 *  Evaluate the quality and integrity of study site practices related to the
proper conduct of the protocol and adherence to applicable regulations. Escalate
quality issues to Clinical Team Lead (CTL) and/or line manager
 *  Manage the progress of assigned studies by tracking regulatory submissions
and approvals, recruitment and enrollment, case report form (CRF) completion and
submission, and data query generation and resolution
 *  Create and maintain appropriate documentation regarding site management,
monitoring visit findings and action plans by submitting regular visit reports
and other required study documentation.

Endogastric Solutions
Redmond, WA
Apr 2005 to July 2007 Clinical Research Associate II
 *  Assist in developing and writing trial protocols (outlining the purpose and
methodology of a trial)
 *  Coordinate all activities required to initiate, monitor and complete
clinical programs. Conduct initiation, monitoring, and close-out visits.
 *  Manage regulatory authority applications and approvals 
 *  Manage SAE follow up and reporting to regulatory bodies and sites
 *  Data management and source data/document verification (SDV)
 *  Write visit reports and manage query resolution
 *  Assist in data analysis and the preparation of final reports.
Dendreon
Seattle, WA
Nov 2004 to March 2005 Clinical Marketing Coordinator
 *  Marketing of prostate cancer research product (trade fairs, referrals,
etc.)
Benaroya Research Institute
Seattle,WA
Sept 2003 to Sept 2004 Certified Clinical Research Coordinator II
Americas Doctor
Tacoma, WA
Oct 2000 to Sept 2003 Senior Clinical Research Coordinator
Franciscan Medical Group
Federal Way, WA
May 1997 to Oct 2000 Certified Medical Assistant
Pediatrics Northwest
Tacoma, WA
Nov 1995 to May 1997 Certified Medical Assistant
Pediatric oncology
Dr. Lowell Finkleman
Purdy, WA
Feb 1995 to Nov 1995 Medical Assistant
 

Project Experience as a CRA 

Project description 
Description of Responsibilities/Tasks
Phase
 Indication
&
Drug class Number 
Countries Number 
sites & patients Including start and end dates
Phase III 

 Parkinson  's Disease US 50 sites
600 pat Sept 2007  *  Nov 2007
CRA: Coordinate all activities required to initiate, monitor and complete
clinical programs. Conduct Site Selection visits.
Phase III Hematology / Thrombin 

Drug sprayed on surgical site prior to closing to promote hemostasis US 60
sites
400 pat Aug 2007  *  Jan 2008
CRA: Coordinate activities required to initiate, monitor and complete clinical
trial. Conduct Site Selection visits.
Phase II

 Hepatitis B

New drug used to manage chronic Hepatitis B infection World-wide 60 sites
250 pat Aug 2007  *  Present

CRA: Coordinate activities required to initiate, monitor and complete clinical
trial. Conduct monitoring, and close-out visits. One sponsor audit.
Phase III

 Cardiology

Medical management of unstable angina US 100 sites
445 pat Oct 2007  *  Dec 2007

CRA: Coordinate activities required to initiate, monitor and complete clinical
trial. Conduct Site Selection visits.
Phase III HIV US 100 sites
400 pat Nov 2007  *  Apr 2008
CRA: Coordinate all activities required to initiate, monitor and complete
clinical programs. Conduct Site Selection visits.
Phase III Erosive Esophagitis 24 countries 416 sites
 2120 pat Jan 2008  *  Present
CRA: Coordinate all activities required to initiate, monitor and complete
clinical programs. Conduct Site Selection visits.
Phase IV HPV US 100 sites
45000 pat Mar 2008  *  Present
CRA: Coordinate all activities required to initiate, monitor and complete
clinical programs. Conduct Site Selection visits.

Systems Experience/IT Skills 
Windows 98/2000/NT/XP, Microsoft Excel, Microsoft Word, Access/Oracle,
Powerpoint, Internet Explorer, Lotus Notes.

Other Relevant Skills 
Language - English

Membership of Professional Associations 
Association of Clinical Research Professionals (ACRP)