Quality Assurance Clinical Research
Resume:
602-***-**** cell
602-***-**** home office
Phoenix, AZ
Joani C. Blansfield
JCBlansfield Enterprize, LLC
INDEPENDENT CONTRACTOR
Objective Comprehensive knowledge of biomedical product development based on 30 plus
years of experience in clinical monitoring, development, regulatory affairs,
quality assurance and data management in the pharmaceutical and medical
device industries. Participated in many phases of the quality assurance
auditing process for drug and medical device developments. Management of
regional field personnel for project management in field operations.
Employment
September 2012- Present
Senior Clinical Research Associate
Contract
Completing a short term contract for a small bio-pharmaceutical company completing source
data verification and eCRF verification. Monitoring of data accuracy, query resolution
and
compliance according to protocol specifications. Verified regulatory files for
documentation
purposes for sponsor's requirements.
April 2012 -September 2012
Parexel INC.
Senior Clinical Research Associate
Contract
Monitoring of clinical research trials, including all phases for GCP, ICH and FDA
requirements:
special assignments on the SWAT for immediate response to issues and site management.
Source verification with source documents into electronic case report forms and query
resolution
for data management. Responsible for assurance of case report data accuracy and
compliance
with protocol requirements for IND submissions. Maintain records for drug accountability,
study supplies and regulatory document files. Travel nationally to all sites conducting
all visits
pertaining to study conduct and transitioning sites.
November 2011- April 2012
Senior Clinical Research Associate
Pfizer Pharmaceuticals/K Force Clinical Research Inc.
12641 North 26th Place
Phoenix, AZ 85032
Contract
Monitoring of clinical research trials including all phases for ICH/GCP compliance.
Source verification with source documents into electronic case report forms and query
resolution for data management. Responsible for case report form accuracy and
protocol compliance required for IND submissions. Maintain records for drug
accountability
and patient compliance, study supplies and regulatory document files. Travel nationally
to sites
performing all required visits for study conduct.
January 2011- November 2011
Senior Clinical Research Associate
Johnson and Johnson Pharmaceuticals
Global Clinical Operations
1125 Trenton-Harbourton Road
Titusville, NJ 08560
(Contract)
Monitoring of clinical research trials including all phases for GCP, ICH and FDA
requirements, specializing in oncology: prostrate cancer, breast cancer,
smoldering myeloma and multiple myeloma. Source verification with source documents into
electronic case report forms and query resolution for data management. Responsible for
assurance of case report form data accuracy and compliance with protocol requirements for
IND submissions. Maintain records for drug accountability, study supplies and regulatory
document files. Travel to regional sites conducting pre-study, initiation, interim and
close-out study visits required for monitoring and transitioning study sites. Site
management regarding study conduct including enrollment discussions, study conduct, site
assessments and training site personnel.
August 2002-November 2010
Regional Clinical Research Monitor
Forest Research Institute
Harborside Financial Center, Plaza V
Jersey City, NJ 07311
Monitoring of clinical research trials including all phases for GCP, ICH and FDA
requirements. Prepare computerized reports for visits and compliance according to
corporate SOP's. Source verification with source documents into electronic case report
forms and query resolution for data management. Responsible for assurance of case report
form data accuracy and compliance with protocol requirements for IND submissions.
Maintain records for drug accountability, study supplies and regulatory document files.
Travel to regional sites conducting pre-study, initiation, interim and final study visits
required for monitoring and co-monitoring. Site management regarding study conduct
including enrollment discussions, study conduct, site assessments and training site
personnel.
April 2000- August 2002
Regional Clinical Research Monitor
PharmaNet, Inc.
Blue Bell, PA
Independent Regional Clinical Monitor-Contractor
Scottsdale, AZ Home-based
Monitoring of clinical research trials including all phases for GCP and ICH compliance.
Responsible for assurance of case report form data for accuracy for NDA submissions.
Prepare computerized reports for visits and compliance according to corporate SOP's.
Maintain records for drug accountability, study supplies and regulatory document files.
Travel to regional sites conducting pre-study, initiation, interim and close-out study
visits
for required monitoring.
1998-2000
Regional Clinical Research Monitor
Kern McNeill International
Chatham Township, NJ 07928
Monitoring of clinical research phase II, III, IV studies for GCP and ICH compliance.
Assist
in assurance of remote data entry of case report forms for accuracy. Responsible for CRF
design and NDA submissions for sponsors. Travel 50-75% to regional sites for pre-study,
initiation, interim monitoring and close-out visits. Prepare written reports for all
visits and
for compliance according to corporate and sponsor SOP'S. Maintain records for drug
accountability, study supplies and regulatory document files.
1997-1998
Senior Clinical Research Associate
Independent Regional Clinical Monitor
Scottsdale, AZ Home-based
Biomedical product development participated in many areas in the conduct of multi-center
clinical research studies; reviewing project-related materials and literature to develop a
basic understanding of the protocol and therapeutic areas; participated and presented at
investigator meetings for assigned studies; assisted in investigator recruitment;
evaluated,
initiated, monitored and closed out sites according to applicable sponsor global standard
operating procedures (SOPS) and FDA guidelines; reviewed case report forms for
completeness, clarity legibility, conformity to available source documentation, and
adhered
to protocol requirements; resolved CRF discrepancies and/or clarifications via site visit,
telephone or fax as deemed appropriate for the study; performed drug accountability,
reported adverse experiences promptly; verified completeness of critical documents and
regulatory requirements per protocol.
1995-1997
Quality Assurance Auditor/Clinical Monitor
Hill Top Research Inc.
Scottsdale, AZ
Assisted Site Manager in assuring that Hill Top Research procedures complied with
Federal Regulations, company policies and SOP's. Performed inspections of ongoing
studies and reported results to study personnel. Performed audits of final study reports
and reviewed results to personnel. Inspected facility audits in four nationwide
locations.
Traveled 35-50% for inspections of clinical and non-clinical areas. Managed a team for
Quality improvement, revision of Quality Assurance SOP's and QA files for client based
projects. Achieved and maintained a knowledge of quality as it pertains to industry
standards. Assisted in developing and implementing training programs for branch personnel
in four therapeutic areas.
1993-1995
Senior Clinical Research Monitor
Harris Laboratories
Phoenix, AZ
Responsible for Phase II, III and IV, clinical research studies, data management, CRF
design, protocol development, and NDA submissions for sponsors. Evaluated and
monitored clinical study sites to assure adherence to Good Clinical practices (GCP's).
Responsible for sponsor interaction, and facilitated cooperative communication with
study personnel for project success.
1992-1993
Clinical Research Study Coordinator
Harold Udelman, M. D.
Phoenix, AZ
Responsible for four clinical studies. Evaluated patients for protocol qualification,
drug dispensing, compliance and protocol adherence. Clinically evaluated patients and
collection of data via source documents and CRF accuracy in accordance with study
requirements. Interfaced with study personnel and study sponsors. Attended
Investigator's
meetings as necessary for study conduct.
1989-1992
Consulting
IOMED
Salt Lake City, UT
Assisted Project Director consulting on data management procedures for data analysis,
Reviewed CRF's for completeness, clarity and corrections for processing for
computerization.
Assisted in the coding of concurrent medications by therapeutic areas, and adverse events
by body systems for statistical analysis.
1986-1988
Clinical Project Supervisor
IBRD
Newport Beach, CA
Responsible for the supervision of a 35 member project based team. Coordinated the
development of project operations and data entry procedures. Reviewed project reports
ensuring accuracy and meeting deadlines. Identified problems and issued recommendations
for improvement. Recruited, hired and trained staff to meet clinical study
project completion dates. Responsible for 10 clinical drug studies, including
anti-inflammatory, antidepressant cardiovascular, duodenal ulcer and cancer research
projects.
Developed and co-authored the department SOP's to insure Good Clinical Practices (GCP's).
Responsible for sponsor interaction and procedure orientation. Assisted in preparation of
NDA for drug approval for Voltaren.
1984-1986
Clinical Systems Analyst Manager/ In-house Clinical Monitor
ICN Pharmaceuticals
Costa Mesa, CA
Responsible for preparation of clinical data, including all processing on the DEC,
Microvax 11 using UNIX, BMPD, P-Stat, Lyrix and Informix software. Supervised and trained
the clinical trials data processing staff and biostatical consultants. Proposed and
installed a computer system to handle documentation and data entry for all clinical
trials in support
of FDA submissions. Assisted in preparation of all documented packages for drug and
device regulatory submissions to the FDA. These included a new chemical entity NDA that
resulted in the approval of Ribavirin, a broad-spectrum antiviral drug. Trained five
Clinical
Research Associates in CGP's and regulatory compliance. Assisted in the preparation of
clinical protocols, clinical and regulatory SOP's, CRFs, informed consents and monitoring
of
clinical studies.
1977-1983
Research Data Coordinator
Astra-Zeneca Pharmaceuticals, Stuart Pharmaceuticals, ICI Americas
Wilmington, DE
Responsible for project development and preparation of data for clinical trial analysis
reports and databases. Experienced in MIS and information processing including
information storage and retrieval, data modification, report generation, ( tables, charts,
grafts, and text) statistical data analysis, debugging programs, distributed data entry,
coding and screen design. Developed and executed computer applications on the IBM
3033N operating on VMS. Experienced in TSO/SPF. Programming experienced in SAS, COBAL,
UNIX, Basic and C. Assisted in the preparation if NDA's that resulted in drug approvals
for Tenormin, Cefetetan and Nolvadex.
Education Neumann University
Aston, PA
B. S. Biology and Computer Science 1982
Nursing School of Wilmington
Nursing Diploma RN 1977
UCLA
Los Angeles, CA
Graduate courses in Management Information Systems 1985-1986
Interests Reading, Swimming with the Scottsdale Master's Program, Sewing
Professional Drug Information Association
Regulatory Affairs Professional Society
Society of Quality Assurance
ACRP
KRONOS Research Foundation
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