Management Data

Natasha S. Keyes

***** *****

Detroit, MI *****

Phone: 770-***-****

Email: abhnxn@r.postjobfree.com

________________________________________________________________________

Qualifications

. Clinical Research professional qualified by over 10 years of

visible achievements in Reference Laboratory and CRO.

. Knowledgeable in areas of third party testing, sponsor protocol

review, budgeting, LIMS, UNIX, CITRIX, SOP's, ICH regulations,

GCP, and clinical research.

. Demonstrated competencies in managing clinical trials data,

formulating source documents and data collection and severe

adverse event reporting.

. Proven reference coordination abilities with capacity to design,

plan and implement ideas from conception through completion;

able to manage multiple responsibilities without compromise to

detail or quality.

Experience

2010-Present MMS Holdings, Inc., Oncology Data Abstractor

. Attend biweekly medical writers meeting to report project

status and updates.

. QC/QA clinical documents such as CSRs, study protocols,

MedWatch Review, Investigator Brochures, and patient

narratives prior to regulatory submission.

. Prepare clinical patient narratives.

2010-2010 Karmanos Cancer Institute, Cancer Registrar

. "bstract oncology data from patient records with regards to

first state of diagnosis, course of treatment, and follow-

up treatment status in accordance to SEER and the

Commission on Cancer standards.

. Accurately code all cancer cases using ICD-O codes.

. Perform procedures for accurately identifying and staging

all cancer cases according to AJCC guidelines.

. Attend monthly educational activities of the State Tumor

Registrar Association.

2006-2009 Quintiles Transnational, Technical Support

Specialist

. Scope of responsibilities included reviewing protocols,

CRF's, data management plans, identifying inconsistencies

in accordance to sponsor protocols with regards to testing,

and sample management.

. Participated in quality improvement initiatives, reviewed

SOP's, and reviewed monitoring reports.

. Resolved data discrepancies and ensured complete and

accurate data by reviewing source documents.

. Worked with Management Teams to determine qualifying

testing needs per global region and monitoring for all

phases of clinical trials.

. Assisted with study start-up and close-out plans.

. Collaborated directly with third party vendors to ensure

proper testing, pricing, and patient data according to

sponsor protocol requirements.

. Tracked and documented patient data received from third

party sourcing through designated interface or manually.

. Responsible for overseeing all phases of clinical trials

and initial third party vendor budgeting negotiations;

acted as liaison with business developers and third party

vendors for contract negotiations to meet pharmaceutical

company requirements.

2006-2006 Laboratory Corporation of America, Laboratory

Specialist/Reference

. Managed regulatory documents, technical and non-technical

procedures required to process and submit specimens.

. Assigned specific computer generated identification

numbers, checked for accuracy, and recorded all items

processed.

. Set up microbiology cultures according to protocols.

. Maintained hospital reference lab interface for LabCorp

results.

. Provided the Laboratory Director updates with respects to

the error logs for hospital reference testing.

. Trained Lab Technicians/Supervisor on Send-Out procedures

and processing techniques.

2002-2006 Quest Diagnostics Laboratory, Test Reference

Coordinator

. Organized specimens for laboratory and clinical trial

testing.

. Retained active records of samples sent to reference labs

for testing, and ensured the receipt of results.

. Find missing specimens and make corrections for any wrong

specimens shipped to referral laboratories.

. Arranged and built specimens for Quest Diagnostics and

contracted reference labs for further testing.

. Inspect/package specimens according to the IATA regulations

for main lab as well as other contracted reference labs.

. Trained employees on Send Out procedures and processing

techniques.

. Prepared a Send Out training manual for new employees.

. Acknowledged twice as a Take a Bow recipient for being an

exceptional team player and role model.

Education

Grambling State University Grambling, Louisiana

B.S. Biological Sciences May 2000

University of Phoenix Online Phoenix, Arizona

MBA Business and Global Management 39/45 credits

Walden University Online

M.S. Clinical Research Administration Nov 2012

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