CRA/Sr. Data MAnager/Coodinator/Consultant

Objective: To obtain a position in the scientific community that utilizes my skills

HIGHLIGHTS OF QUALIFICATIONS

Experienced and published clinical researcher
Excellent teacher and trainer of support staff in the field
of research(In Academia,taught laboratory histology techniques to students)(In industry, taught medical staff how to conduct
clinical trials)
Unique ability in multi-task and problem solving
Expert in policy development and research protocol/organize
dataanalysis (CRF, queries, Adverse Events)
In-depth knowledge of computer and computer software programs
In-depth knowledge of FDA Regulations, GCP, and ICH (HIPPA)
Clinical Research Experience as a Consultant,specializing in
Oncology
Experienced Clinical Research Associate CRA(Monitor) for ••••• years(Interim Monitoring, Initiation,Close-out of Medical sites)
Experienced Data Manager for ••••• years and Project Data Manager
for 6 years(data collection and data entry timelines)
Experienced Clinical Study Coordinator for ••••• years conducting research
Experienced in the following Therapeutic areas:

Oncology (breast,breast bone marrow transplant,lymphoma,
melanoma,sarcoma,myeloma,prostate,and Hodgkins and non-
Hodgkins disease,leukemia, lung)
Infectious Diseases (HIV, AIDS, Sepsis,Septic
Shock,Hepatitis A, B,Non-A, Non-B, osteomyelitis
Anti-Infectives pneumonia,flu,vaccines,hemorrhage)
Neurology(epilepsy)
Cardiovascular (stress devices, CNS)
Dermatology (Rosasea, dermatitis)


RELEVANT CLINICAL EXPERIENCE AND WORK HISTORY

Clinical Research Associate (CRA)/Contractor/Consultant
(self employed •••••/•••••/•••••)
Case study evaluation, initiation,monitoring,interim-monitoring, co-monitoring, and close-out visits.
Proficient in query solution,site evaluation,review of patient
records and other source documentation, site quality assurance,FDA guidelines,SOPs,ICH,GCPs, and other regulatory documents. Trained physicians, nurses,data managers,and other personnel in conducting clinical trials.
Maintained drug accountability for pharmaceutical clinical trials. Audited medical sites.
Developed project standards,case report forms, and initiation booklets. Travel between •••••%

•••••/•••••/••••• Johns Hopkins Adult Emergency Medicine
Phase 1 Pilot Study on Timelines and Activity evauations
of emergency care Baltimore, MD

•••••/•••••/••••• Johns Hopkins Oncology Center for Quintiles
Phase II Leukemia Baltimore, MD
NIH/NCI Department of Therapeutic Environment
Closed outPhase II Parkinsons Disease Bethesda,MD

•••••/•••••/••••• OTSUKA America Pharmaceuticals Rockville, MD
Department of Cardiovascular(Claudation-perpherial disease)
Phase IV cardiovascular trial. Review, query. and clarify
CRFs and Safety Reports of ••••• sites. Co-Monitored as
Sponsor CRA with CROs CRAs in data management. Assist
Senior Project Manager on the study with closeout, storage
of documents,and safety data.

•••••/•••••/••••• NIH/NCI Department of Surgery Bethesda,MD
Phase III Melanoma Study. Review, query, and clarify
data for a parmaceutical company(MEDERAX). Train both
the Data Managers and the pharmaceutical clinical Monitors
(CRA) on the project.

•••••/•••••/••••• PAREXEL Pharmaceutical International
East Coast Regional Home-based Office Baltimore,MD
Phase III-IV Ovarian Oncology tria. Monitored 1 sites.
Initiated ites and participated in team meetings, staff
meetings and company training. Qualfied ••••• sies to an
arthitis study and initiated ••••• sites for a breas cancer
study. Travel •••••%.

•••••/•••••/••••• Franklin Square Hospital/Surgical Oncology
MEDSTAR/NSABP Baltimore,MD
CRA in house Phase III-IV NSABP Clinical Trials in brease
prostate, and melanoma. Monitored the ••••• affiliates that
participated on the NSABP trials in the Baltimore-Washington
area. Travel •••••%
Assisted the pysicians wth patient care and preparation of
IL2 and interferon vaccine in the Surgical Oncology Research
laboratory for melanoma patients on study.

3/•••••/••••• OTSUKA AMERICA PHARMACEUTICALS, Inc. Rockille,MD
CRC responsible for cleaning-up data on 4 Phase II-IV
closed double-blind trials dealing with dug Apriprazole and
Schizophrenia. Communication with ••••• sites, clarified data
discrepancies, generated DCFs and using ORACLE vildated data
to Level ••••• Qualified assurances in finalizing 3
cardioascular studies for publcation of data. Projects were
approved by FDA.

•••••/•••••/••••• JOHNS HOPKINS HOME HEALTH CARE Baltimore,MD
Clinical Data Coordiantor (CRC) Track and verified verbal
orders and certifications of treatment plans from Hopkins
and non-Hopkins physicians that treat home healthcare
patients. iited the Outpatients physicians offices to
collect signed verbal orders. Travle •••••%.

•••••/•••••/••••• PPD PHARMACO,Inc. CRO(In-house)Columbia,MD
Clnical Research Associate II (CRA-Regional)
Assist investigator recruitment for Phase II-IV clinicla
trials. Participate in evaluating, initiating, monitoring
and intrim monitoring, and close-out visits for ••••• sites
in 3 diferent theraeutic areas: uterine leiomyomaa in pre-
menopausal women,popular rosasea,and chronic pain
management. Verified source documentation according to FDA
guidelines for completeness,adverse event reports,queries,
and drug accountability. Development of project standards,
case forms,and Initiation booklets for projects. Assist
in the training of new CRAs with monitoring visis and
evauating of sites. Travel •••••%

•••••/•••••/••••• Clinical Research Associate (CRA)/Consultant
Premier Research Worldwide Philadelphia,PA
GBMC Greater Baltimore Medical Center)East Baltimore,MD
Recruited expereinced CRAs to join new biotech company on
the East Coast. Identified and recruited ••••• sites for an
oncology Phase III-IV breast cancer transplant study.
Travel •••••%. Recruit and monitor sites in Maryland and
Washington,D.C. for a cancer pain protocol and
cardiovascular device project. Travel •••••%
Coordinated a project for Substance Abuse and Mental Health
Program for the Mayors Initative Project in Baltimore at
GBMC where substance abuse clients were interviewed,
randomized for treatment,and followed for enhancement

•••••/•••••/••••• IBRD Rostrum Global Irving,CA (home based regional)
Regional Clinical Research Associate Baltimore,MD
Responsible for onitoring ••••• medical sites with 3 different
clinical double-blind projects in trama,epilepsy, and
abdominal antibiotic studies. Initiated 5sites and monitored
several other sites for Aviron-flu vaccine double-blind
Phase II study. Queried data, drug shipment and drug account
submission of site reports,reviewd IND reports,consent forms
and other regulatory documetns. Qualifid assurances of sites
and participated in internal audits. Trained physicians and
nurses and study site personnel while attending investigator
meetings. Completed ••••• pre-Study,••••• Initaition,••••• month
interim monitoring visits,and 5 close-out visits. Travel •••••%

Study Coordnator and Project Manager

Introduced, monitored, and maintained quality control of protocols in Community programs and clinics. Organized, monitored, and implemented audits of local and regional sites with FDA guidelines. Analyzed statistical data and clarified
discrepancies. Wrote annual reports and grant proposals.
Reviewed patient medical records, scheduled follow-up visits, and obtained study specimens. Recruited local physicians to participate in •••••tained Regulatory documents for IRB approval (Informed Consent and Protocol •••••ked and verified verbal orders and certification of treatment plans.
Conducted radioimmunoassay (P••••• and I•••••) using rats, mice, and •••••dated the use of HIPPA at medical clinical sites.

•••••/•••••/••••• RAW CRAWLY SHOCK TRAMA Baltimore, MD Dept of
Infectious Diseases Univeristy of MD
Clinical Coordinator responsible for coordinating and
monitoring clinical trials with trama patients having sepsis,
septic shock, osteomyeltist, and intra-abdominal infections.
Review patients medical records,schedule follow-up visits,
and obtain study patients •••••it IND,consent forms

•••••/•••••/••••• Baltimore Community Research Initiative Program (BCRI) AmFAR Project/HIV/AIDS Clinical Trials Baltimore,MD


Project Data Manager

Organized and implemented new structures of data operation and •••••onsible for the randomization and registering of patients for oncology and infectious diseases clinical trials.
Obtained consent forms,reviewed source documentation and eligibility checklists
Monitored ••••• double-blind cancer trials with a database of ••••• patients. Reviewed, queried, and clarified data for data entry and monitored data entry
Collected patient data and reviewed source documentation on flow sheets and case report forms. Travel •••••%.

•••••/•••••/••••• Johns Hopkins Oncology Center, Baltimore,MD
Eastern Cooperative Oncology Group &
New Agents and Pilot Studies Program (ECOG/NAPS)

•••••/•••••/••••• Johns Hopkins Oncology Center Baltimore,MD
Eastern Cooperative Oncology Group) ECOG

EDUCATION
••••• Masters of Science Physiology/Zoology
Howard Univeristy Washington, D.C.
••••• Bachelors of Science Biology/Pre-Med
Morgan State College Baltimore,MD
••••• American Medical Technology MLT Program
Georgetown School of Arts & Sciences Washington,D.C.

CONTINUING EDUCATION

••••• GCP,ICH, SOP Training Various CROs &pharmaceutical
companies
••••• HIV in ADULTS
University of Maryland Baltimore MD
••••• Continuing Studies in Oncology
Johns Hopkins Oncology Center
••••• Special Student in Epidemiology
Johns Hopkins School of Public Health & Hygiene
(••••• credits)

LANGUAGES Scientific German 3 years; Spanish 5 years

COMPUTER EXPERIENCE
Windows•••••; Microsoft Word•••••; Micro Access; WordPerfect, MS Excel, Excel •••••, Powerpoint; DbaseIV; Quarto Pro; Lotus, SAS, MultiMate; programs in Apple-Macintosh; Oracle, FS-Data Systems, Electronic-Database; PC, Gateway •••••, IBM. Dell, Toshiba, Compaq

PUBLICATIONS

Dissertation
A Demonstration of the Release of the Cardioaccelerator from the Corpus Cardium of Blaberus giganteus(l) Howard University, •••••

Publications

An Electrograph Analysis of the Primary Cardiac Arrhythmias and their Effect on PQRST Complex. Journal Of the American Technologist. Sept/Oct.(•••••)•••••

Decrease Dopamine Turnover in the Median Eminence in Response to Suckling in the Lactating Rat. Brain Research. (•••••) ••••• •••••

The Lateral and Medial Median Eminence: Distribution of Dopamine, Norepinenphrine, Lutenizing Hormone-Releasing Hormone and the Effects of Prolactin on Catecholamine Turnover. Endocrinology (Vol•••••) No••••• •••••

The Enzymatic Syntheses of L-Asparagine. Analytical Biochemistry. •••••

Micromethod Analysis of Total Plasma Cholesterol Using Gas Chromatography from Prostatic Cancer Patients. Journal of Physiology. •••••

Theophylline as an Inhibitor in Effect Metastases on the Morris Hepatomas. Journal of Biochemistry. •••••

Antilocalization Following Mammal Focal X Irradiation on the Morris Hepatomas. Analytical Biochemistry. •••••

Relevant Teaching and Activities Experience
Swim Coach for ••••• years of a Black Synchronized Swim Team
Tutored piano lessons to the neighborhood children
After school tutor for neighborhood adults to obtain their GED
Swim teacher in Life Saving, canoeing, and sailing at summer
camps for 5 years
Teacher of arts and crafts at a summer camp
First Girl Scout Leader in the Western District to have her
own troop (at ••••• years)
Girl Scout Western District Cookie distribution Leader
Second positions working with the pubic as a sales person at
various stores: as Sears, Hechts, Loehmanns, Kokopellis, and the Bead

AWARDS and LICENSES

City Pin in Sports (swimming) •••••
Women Black Athletic Award ••••• (coaching and teaching synchronized swim team)
Life Saving and ••••• mile Swim Team
High School Letters (2) for archery and swimming
Art Awards
Professional Technologist licenses (•••••)
SOCRA professional organization (clinical trials)