Data Entry
Resume:
Westfield, IN *****
I am interested in exploring the career opportunity with your
organization, you have available. I have worked steadily throughout the
past six years in the area of Clinical Research Operations. My
experience, coupled with my background as a clinician for large and small
pharmaceutical/CROs, provides me with valuable qualifications, medical
knowledge, and leadership skills that you are seeking in this position.
Throughout my years in the research arena, I have been directly
responsible for the following:
. Regional Clinical Research Associate - Device Studies: Orthopedics
with Medical Devices
. Senior Clinical Research Associate - In House
. Data Management
. Pharmacy Personnel Manager
In addition to my achievements during my career in clinical operations,
my background and expertise as a senior clinical research associate
allows me to be most instrumental on diverse research projects and
therapeutic areas for site management of investigator sites during my
tenure in the pharmaceutical industry:
. Tracking and reviewing of clinical trial database for sponsor
initiated clinical trials
. Regulatory assessment of site compliance of GCP, ICH and FDA
guidelines
. Manage quality assurance and compliance of investigator site in
coordination of all clinical protocol trial activities and maintain
all documentations for compliance
. Design, implement and coordinating clinical trial material per
protocol guideline
. Liaison between Site and Sponsor
. Data manage investigator's site protocol adherence and assurance of
timely enrollment of patients; and the retrieval of CRF's pages
from study sites. For the on-time processing of CRF's pages in data
cleanup and classification of data; for the completion of study
summary and database locks
. Territory selection process of selecting of investigators, monitor
clinical study, and prepare study start-up documents including and
regulatory required documentations
As you can see I am capable to present your organization with advantages
other candidates may not offer. I am forwarding you a copy of my
Curriculum Vitae (CV) highlighting my educational background and
professional experience.
I am motivated and enthusiastic, and would appreciate the opportunity to
contribute to the continued success of your organization. I can promise
that meeting with me will not be a waste of your time-and I will make
myself available at your convenience. Please feel free to contact me at
Thank you for your consideration and I look forward to hearing from you
favorably,
L'Tanya Allen
Objective: Energetic and hardworking individual who works effectively and
efficiently independently and in a team environment with strong
organizational skills and attention to detail.
Skills: WordPerfect, Microsoft Word, Excel, Lotus Notes, AS 400,Impact,
Access, Outlook, Inform, RAVE, COOL/ electronic data capture, e-
Crfs.
Professional Affiliation: Greater than 6 years of industry clinical trial
monitoring experience for industry leading pharmaceuticals and CROs; which
includes clinical trials consisting of Phase I-IV in a variety of
therapeutic areas.
___________________________________________________________________________
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Professional Experience:
PRA International, Charlottesville, VA February 2010-
Present
Clinical Research Associate
. Ensure that all governmental standards are met and the projects
are completed expeditiously
. Generate and track clinical documentation and reports. Travel
60- 75%
. Maintain/manage data entry in designated clinical tracking
system such as reg. document tracking
. Responsible for site selection, initiation, interim and other
trial monitoring activities.
. Responsibilities will include conducting monitoring visits to
the integrity of clinical data with respect to accuracy,
accountability, documentation, and methods or procedures through
review of CRFs, source documents, medical records, and
regulatory documents
. Conduct 100% SDV
. Resolve data discrepancies within timeframe
. A working knowledge of relevant GCP/ICH regulations and policies
and procedures is essential
. Direct the tracking of enrollment rates, receipt and review of
completed CRFs
. Prepare Monitoring Trip Reports and contribute information for
Status Reports for sponsor
. Report Serious adverse Events (SAEs) and reconciles on-site and
in-house reports
ICON Clinical Research, North Wales, PA December 2007- July
2009
Clinical Research Associate
. Ensure that all governmental standards are met and the projects
are completed expeditiously
. Generate and track clinical documentation and reports. Travel
60- 75%
. Maintain/manage data entry in designated clinical tracking
system such as reg. document tracking
. Responsible for site selection, initiation, interim and other
trial monitoring activities.
. Responsibilities will include conducting monitoring visits to
the integrity of clinical data with respect to accuracy,
accountability, documentation, and methods or procedures through
review of CRFs, source documents, medical records, and
regulatory documents
. Conduct 100% SDV
. Resolve data discrepancies within timeframe
. A working knowledge of relevant GCP/ICH regulations and policies
and procedures is essential
. Direct the tracking of enrollment rates, receipt and review of
completed CRFs
. Prepare Monitoring Trip Reports and contribute information for
Status Reports for sponsor
. Report Serious adverse Events (SAEs) and reconciles on-site and
in-house reports
Pivotal Research Solutions, Allen, TX
Regional Clinical Research Associate-Device Studies April
2005- December 2007
. Ensure that all governmental standards are met and the projects
are completed expeditiously
. Generate and track clinical documentation and reports. Travel
60-75%
. Maintain/manage data entry in designated clinical tracking
system such as reg. document tracking
. Responsible for site selection, initiation, interim and other
trial monitoring activities.
. Responsibilities will include conducting monitoring visits to
the integrity of clinical data with respect to accuracy,
accountability, documentation, and methods or procedures through
review of CRFs, source documents, medical records, and
regulatory documents
. Conduct 100% SDV
. Resolve data discrepancies within timeframe
. A working knowledge of relevant GCP/ICH regulations and policies
and procedures is essential
. Direct the tracking of enrollment rates, receipt and review of
completed CRFs
. Prepare Monitoring Trip Reports and contribute information for
Status Reports for sponsor
. Report Serious adverse Events (SAEs) and reconciles on-site and
in-house reports
. Monitored device studies for the spine, knee, ankle and heart device.
Medfocus
Contractor for Eli Lilly and Company, Indianapolis, IN
October 2003 - April 2005
In-House Monitor
. Design paper CRF and eCRFs, develop and review documents which
outlined the study-specific computer edit check descriptions, presents
CRFs and instructions in affiliated training or start-up meeting.
Review CRFs data for completeness, generate queries and resolve data
discrepancies within timeframe
. Assures data consistency across trial subjects, clinical research
units, also assuring global consistency of clean locked database.
Participate in data lock discussions. Responsible for site selection,
initiation, interim and other monitoring activities
. Direct the tracking of enrollment rates, receipt and review of
completed CRFs and grant documentation to ensure the efficient
execution of a clinical trial, Manage in house documentation of all
sites study documentation
. Responsibilities includes conducting local monitoring visits to the
integrity of clinical data with respect to accuracy, accountability,
documentation, and methods or procedures through review of CRFs,
source documents, medical records, and regulatory documents.
. Assures responsibility for the integrity and completeness of required
database tracking tools per project requirements
. Arrange and lead study development meetings and coordinate all daily
activity of clinical trials, Prepare and review timelines and metrics
participate in process improvements. Utilize Who Drug Dictionary for
drug research
. Responsibilities will include conducting local monitoring visits
to the integrity of clinical data with respect to accuracy,
accountability, documentation, and methods or procedures through
review of CRFs, source documents, medical records, and
regulatory documents.
. A working knowledge of relevant FDA/ICH regulations and policies
and procedures is essential
. Monitoring in-house clinical trials such as IBS, GI and Women's
Health
Kelly Scientific Resources
Contractor for Eli Lilly and Company,
January 2001- September 2003
Data Management- Study Coordinator
. Responsible for global data quality and consistency within the
clinical data management infrastructure which includes data
collections, data validation, data archiving and enforcement of data
standards
. Assures data consistency across trial subjects, clinical research
units, also assuring global consistency of clean locked database. Test
database prior to implementation/testing of data entry/edit system,
Create and review data reports/listing to ensure quality. Develop data
validation plan and validate data for global data quality and
consistency
. Support development of data collection materials and apply specialized
therapeutic area knowledge to review and validate data to ensure
database consistency and accuracy, Maintain validation for oncology
research studies
. Data validation of scanned CRFs and maintained validation log,
Communicated lab issues to Clinical Diagnostic Services
. Aided in the collection and interpretation of metrics and participate
in process improvements
. Created, sent and resolved all necessary queries, using AS400
. Ensure all external data/ancillary data was uploaded, also ensure
databases matches host
. Infrastructure that includes data collections, data validation, data
archiving and enforcement of data standards
. Coordinating clinical trials such as GI, Endocrinology and CNS
St. Mary's Medical Center, Gary, IN
February 1990 - December 2000
Study Coordinator
. Responsible for global data quality and consistency within the
clinical data management infrastructure which includes data entry,
data collections, data validation, data archiving and enforcement of
data standards
. Assures data consistency across trial subjects, clinical research
units, also assuring global consistency of clean locked database. Test
database prior to implementation/testing of data entry/edit system,
Create and review data reports/listing to ensure quality. Develop data
validation plan and validate data for global data quality and
consistency
. Support development of data collection materials and apply specialized
therapeutic area knowledge to review and validate data to ensure
database consistency and accuracy, Maintain validation for oncology
research studies
. Data validation of scanned CRFs and maintained validation log,
Communicated lab issues to Clinical Diagnostic Services
. Aided in the collection and interpretation of metrics and participate
in process improvements
. Created, sent and resolved all necessary queries, using AS400
. Ensure all external data/ancillary data was uploaded, also ensure
databases matches host
. Infrastructure that includes data collections, data validation, data
archiving and enforcement of data standards
Pharmacy Tech Manager
February 1982 - February 1990
. Responsible for mentoring and managing incoming pharmacy technicians;
up to twenty technicians at any given time
. Responsible weekly scheduling of all technicians on day and evening
shifts
. Ensure that all clinical, operating rooms, emergency room, and
subspecialty clinics were stock with specified dosage and unit dose
medication
. Responsible for daily metric reports for specified units and clinics
of order medications
. Responsible for mixing TPNs, Chemo, piggybacks, NICU
. Responsible for fill in-house and discharge order medications for
patients
. Responsible for logging all prescriptions in patient's profile
Education: June 1981 South Suburban College, South Holland, IL
Associate Degree-Pharmacology
Other Certifications:
National Certified Pharmacy Technician
Therapeutic Areas:
Cardiovascular
CNS Gastrointestinal (GI)
Endocrinology Women's Health
Infectious Disease
Vaccine
Pediatrics Hypertension
References
Upon Request
Contact this candidate