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Technician Quality Control

Location:
Houston, TX, 77382
Salary:
60,000
Posted:
January 24, 2011

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Resume:

Bernice Wilson-Newman

** ***** **** *****

The Woodlands, Texas 77382

281-***-**** h

281-***-**** c

hekqgr@r.postjobfree.com

Objective

I have extensive research experience in the therapeutic areas of HIV and Oncology. My skills include supervision of staff, phlebotomy, processing and shipment of samples, recruitment and enrollment of patients for research studies. I am detailed oriented with strong organizational skills. My excellent interpersonal skills have allowed me to professionally communicate with PI’s, research nurses, sponsors, monitors and patients. I desire to work for a growing, people oriented CRO or healthcare organization where I can utilize my broad experience, exceptional clinical research knowledge and be awarded for measured achievements and accomplishments.

Employment History

UT MD Anderson Cancer Center ~ Houston, Texas Feb. 2006-June 2009

Clinical Data Specialist

• Maintained a system for controlling paper flow for protocols by developing spreadsheets or other tracking tools for relevant protocol/patient data

• Assisted with protocol data preparation for monitoring/auditing visits

• Reviewed sample tracking database and source documentation to prepare samples for monitor/audit visits

• Maintained a system for coordinating/scheduling monitor visits

• Assisted in the preparation of daily CIT work list and assignments

• Assisted in the preparation of scheduled status reports by using institutional databases (PDMS, CARE, Clinic Station, Cerner)

• Attended protocol start-up meetings with sponsor company representatives and MDACC clinical personnel to assure sample collection procedures and forms are fully understood

• Solicited information from Sponsors, Principal Investigators, Research Nurses, and Monitors to clarify protocol requirements

• Documented receipt and management of study supplies and assist in maintaining required inventory

• Monitored and assisted with the process of scheduling treatment and lab specimen collection times in CARE and CTRC databases

• Researched queries regarding lab charges

• Generated routine reports on sample collections and study sample requirements upon request

• Provided assistance in gathering data for metrics and prepared performance reports for individual CIT’s

• Participated in quality review of samples and shipping information

• Prepared and maintain database for tracking specimens with high level of accuracy

• Performed all laboratory functions in compliance with safety guidelines, policies, and procedures while adhering to regulatory mandates (e.g. GLP, CAP, CLIA, and JCAHO)

UT MD Anderson Cancer Center ~ Houston, Texas Feb. 2006-Aug. 2008

Supervisor, Clinical Investigational Technician

• Responsible for overall supervision of activity in CTRC (Clinical Translational Research Center) Lab on a daily basis

• Assigned work to CIT’s (Clinical Investigational Technicians) based on workload and patient availability

• Reviewed clinical trial protocol procedures and coordinated sample collection, processing, shipping and storage of research samples with research nurses and PI’s conducting the study

• Responsible for overseeing and performing sample collection, processing, and shipment for over 140 (Phase I-IV) pharmaceutical industry research protocols, NCI, and investigator initiated studies being conducted at MD Anderson Cancer Center

• Obtained blood samples, performed complex sample processing for pharmacokinetics, pharmacodynamics, and PBMC’s, and prepared shipment of samples per sponsor requirements

• Trained new CIT’s and current personnel in the execution of new protocols

• Modified receipt of new supplies and created a database for study kits to monitor usage and order kits as needed to maintain steady workflow

• Assisted in the monitoring of sample quality control

• Expedited phone calls from PI’s, research nurses and study coordinators to resolve issues affecting protocol execution

• Provided assistance in revising standard operating procedures

• Responded to queries from sponsors and or research laboratories

• Successfully implemented a catalogue process for laboratory samples

• Represented laboratory in startup/site initiation meetings

• Worked with clinical study monitors at site visits

• Prepared and organized source documents, data and blood samples for monitor to review on visits

• Ordered protocol specific kits and supplies

University of Illinois Medical Center ~ Chicago, Illinois Feb. 2004-Nov. 2005

Phlebotomy Supervisor/Medical Lab Technician

• Supervised and coordinated the activities of seventeen inpatient and outpatient phlebotomists

• Prepared and conducted performance management reviews

• Instituted employee discipline and counseling

• Assisted in employee recruitment and interview process

• Assisted in payroll and clock work preparation

• Devised staff schedules

• Reviewed and updated phlebotomy procedure manuals

• Conducted periodic staff meetings

• Participated in laboratory continuing education programs

• Ensured continuous workflow of the laboratory by working closely with other supervisors

Health Partners America ~ Cook County Hospital ~ Chicago, Illinois April 2002-Dec. 2003

Immunology Technician

• Examined blood samples for various serological diseases such as syphillis, VD and mononucleosis.

• Operated Immage Immunochemistry System (Nephelometer) for the quantitative determination of protein chemistries.

Hektoen Institute for Medical Research ~ Chicago, Illinois Mar. 1999-Mar. 2002

Health Educator/Lab Technician

• Promoted the use of rapid HIV testing using SUDS, MYRIAD, and ORASURE methodology.

• Recruited high risk clients according to protocol requirements.

• Performed laboratory test and data analysis as determined in the research study protocol.

• Trained labor & delivery clinical staff on MYRIAD testing at Cook County Hospital.

• Performed ORASURE testing in the penal system (Cook County Department of Corrections).

• Obtained blood samples and provided informed consent for clients interested in HIV status.

• Conducted outreach to assess the target population’s needs, provided education, and offered risk reduction strategies.

• Assessed client’s knowledge of HIV transmission and provided AIDS information. Assisted with facilitation of focus groups and evaluation of services.

• Established new product networks and broaden existing ones with community organizations, service providers, and institutions.

• Participated in staff development meetings and provided accurate and timely documentation of education and or services provided.

• Linked HIV+ patients into primary health care system.

• Assisted in grant writing

GeneScreen ~ Chicago, Illinois June 1996-Mar.1999

Phlebotomy Supervisor

• Supervised and directed a staff of four. Recruited and trained staff interacted with attorneys, judges, and other court appointed personnel.

• Obtained blood samples and buccal swabs for DNA paternity testing.

• Coordinated blood samples from Cook County Coroner’s Office, Department of Corrections, and the general public.

Education

Walden University ~ Baltimore, MD ~MS Clinical Research Administration (anticipated graduation date) May 2011

Benedictine University ~ Lisle, IL. ~ B.A. in Management May 2005

Certifications

CITI Collaborative Institutional Training Initiative Jan. 2009

Good Clinical Practice Curriculum

Responsible Conduct of Research Curriculum

National Credentialing Agency for Laboratory Personnel (NCA) May 2008

Clinical Laboratory Phlebotomist (CLPB)

University of Texas MD Anderson Cancer Center June 2006

Clinical Research Training Program

Abstracts/Presentations

IDSA 37th Annual Meeting Philadelphia, Pa Nov. 1999

Utility of Rapid HIV testing to help determine the need for Post-Exposure Prophylaxis (PEP) in Health Care Workers (HCW’s) exposed to source patients whose HIV status is unknown

2001 National HIV Prevention Conference Atlanta, Ga. Aug. 2001

Expanded Use of Rapid HIV Testing in an Emergency Department

References Available Upon Request



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