Project Manager Training
Resume:
Liza D. M. Gorgon
N. Potomac, MD 20878
Citizenship: United States
Social Security Number: XXX-XX-2841
EDUCATION
Masters of Arts Bowie State University - Bowie, MD
2000
Counseling Psychology Credit Hours - 36
Bachelor of Science Syracuse University - Syracuse, NY
1991
Family and Community Studies Credit Hours - 112
Dual - Psychology
(Required Course Work) University of Maryland - College Park, MD
1991
Credit Hours - 3
(Required Course Work) Montgomery College - Rockville, MD
1989 / 1990
Credit Hours - 9
High School Thomas S. Wootton High - Rockville, MD 1987
WORK EXPERIENCE
Job Title: Clinical Trials Specialist
1991 - Present
Employer: National Institutes of Health
National Institute on Drug Abuse
6001 Executive Blvd - RM 4123
Rockville, MD 20852
Salary: $115,742 / Year
Highest Grade Held: GS-13 / Step 10
Hours per week: 40 hrs / week: Full-time
Duties / Accomplishments:
I participate in scientific, administrative and managerial activities of
the Medications Development project team for a specific compound. As a team
member, I determine the feasibility of the project site, the best mechanism
of supporting the site, and estimating the cost of the project and work
with the scientists and administrators to launch the project. These
responsibilities require a combination of sound judgment, scientific
knowledge of the drug, knowledge of the facility and the ability to assess
the staff at the facility. I review, recommend and respond to requests for
selection of sites for clinical trials, clarification of policies and/or
regulations, information concerning a specific drug, and Food and Drug
Administration (FDA) questions.
As Project Officer on a multi-million dollar interagency agreement I am
responsible for the scientific, clinical and fiscal review of clinical
trial protocols and projects. I review all aspects of the protocols,
including budgets, schedules, staffing, and procedures for recruiting and
retaining subjects; methods for ordering, shipment, storage, inventory, and
distribution of compounds; recordkeeping and reporting systems; quality
control; scientific soundness of protocols; and other related areas. I
request additional information on incomplete or inadequate portions of
protocols. I recommend any technical revisions or modifications of
protocols as necessary. I maintain contact with clinical investigators to
determine the status of trials to advise on changes in procedures and
requirements, and to resolve problems.
As project manager of multi-site clinical trials, I am responsible for
negotiating budgets, confirming data ownership of all sites as well as
Confidentiality Certification. I monitor the progress, compliance and
technical aspects of ongoing clinical trials. I review progress reports to
ensure compliance with approved protocols and adherence to plans, schedules
and budgets. I maintain contact with clinical investigators to determine
the status of trials, advise on changes in procedures and requirements and
resolve problems. I refer medical safety or other problems of such nature
to the appropriate medical monitor on staff. I am responsible for the
overview operations of contract monitors, participating pharmacy groups and
the clinical data coordinating centers.
I participate in the overall program and policy planning with the Chief of
the Clinical Medical Branch, by making recommendations and developing
plans, policies and objectives for drug development teams/projects and
evaluation of program results.
I plan and conduct site visits on institutions conducting clinical trials
to insure compliance with protocols. I insure procedures are being
implemented correctly. I assess the adequacy of the "blinding" of the
study and study medication at clinical sites. I select and review samples
of patient records and insure that records are complete, accurate and
properly protected and that the data is being collected in a systematic
manner in accordance with Health Insurance Portability and Accountability
Act (HIPAA), Good Clinical Practice (GCP), FDA and human rights
regulations. Post visits, I prepare written reports that present my
findings and provide recommend actions to improve operations or correct
deficiencies as necessary. I follow up to insure that appropriate action
is taken in response to audit findings. I schedule and coordinate follow-
up visits as required.
I participate in the preparation of annual reports, protocol and
information amendments, articles, manuscripts and any correspondence
required by the FDA for Investigational New Drug (IND) regulations.
I review and recommend action on requests for payment, extensions,
modifications, amendments, substitutions of key personnel and other related
matters. I attend meetings with contractors / grantees and provide
information on changes in procedures and requirements.
I serve as Project Officer and Assistant Project Officer on clinical trial
monitoring contracts. I develop statement of work and evaluation criteria
for Request for Proposals (RFPs) and Request for Contracts (RFCs), and
prepare justification for noncompetitive procurements. I also provide
scientific/technical/administrative information to members of the
Institutional Review Boards (IRBs) and Data Safety Monitoring Boards
(DSMBs) responsible for reviewing proposals. I evaluate the capabilities
and recommend approval of proposed project directors and staff members. I
negotiate the terms and conditions of approved contracts and monitor the
work and provide guidance to contractors to insure that resources are used
efficiently. I review and approve progress reports and requests for
payment. I conduct progress review meetings to review the contract status,
resolve problems and issues and make recommendations of approval of final
project reports.
I provide advice and consultation to the Division staff and clinical
investigators on regulations concerning the conduct of clinical trials. I
maintain awareness of new developments in the area and implement changes in
regulations and procedures as required.
I assist the Chief, Clinical Medical Branch, in developing, implementing
and interpreting guidelines for clinical trials, especially in areas such
as quality assurance, handling and storage of compounds being tested,
recruitment of participants, recordkeeping, data management and reporting.
I evaluate the effectiveness of current procedures and practices and
determine the need for and develop new or revised guidelines along with
revising guidelines in response to new developments or changes in policies.
I serve as a key team member of the Clinical Trials Portfolio System (CTPS)
database. The CTPS is a web-based application for investigators of
clinical research projects to maintain their study information. This
database serves as a central repository from which the Division provides
data to the National Library of Medicine (NLM) for presentation in a
nationwide database via the internet. I am solely responsible for the
input, maintenance and accuracy of the data for over 20 clinical trial
studies that the Division sponsors. I serve as a primary liaison between
clinical sites and the Division as well as for outside patients and the
medical community to answer any questions, concerns or comments they have
regarding the CTPS.
I represent the Branch, Division and or the Institute at interagency
meetings, symposia, and national or international conferences.
TRAINING
Basic Training Course in Drug Development 1/23-
26/94
Basic Training Course in Clinical Monitoring 2/15-
18/94
Privacy Act and Records Management 9/94
Good Clinical Practices Training Course 12/6-9/94
Social Styles in the Workplace 9/95
Management Seminar Series 2/6-7/96
Conducting Clinical Research Trials 7/17-
18/96
Project Officers Course 1/99
FDA and FDA Inspection Procedures 3/26-27/99
Investigational New Drug Regulatory Training 10/99
Writing Statements of Work (Non Research and Development)
12/99
EEO Training 5/00
Training for Protection of Human Subject Research 5/00
Standards of Ethical Conduct Training 10/00
Data Safety Monitoring Boards Workshop 10/00
Performance-Based Services Contracting (Non R&D) 1/01
Case Report Form Design Workshop 4/01
EEO Training 6/01
Advances in Patient Enrollment and Retention Techniques Workshop
3/02
NIH Computer Security Awareness Course 2/03
Case Report Form Design Workshop 4/03
Developing Clinical Study Budgets 5/03
Human Rights Protection Education for Research Teams 7/03
Advanced Project Officers Course 5/04
Computer Awareness 8/04
Ethics Training 12/04
Information Security Awareness 3/06
Section 508 Training 4/06
Addiction Severity Index Interviewer Certification 4/06
Purchase Card Training 5/06
Green Purchasing Course 5/06
Design and Development for Clinical Trials 8/06
Clinical Statistics for Non-statisticians 9/06
Ethics Training 10/06
No Fear Act 10/06
Critical Thinking for Problem Solving 5/07
Ethics Training 10/07
Federal Information Security Management Act Training 2/08
NIH EEO and Diversity Awareness Training 6/08
Alternative Dispute Resolution 8/08
Ethics Training 10/08
Handling Financial Conflict of Interest 11/08
Information Security Awareness 1/09
NIH Purchase Card Program Refresher Program 2/09
Project Officer Technical Reporting Training Requirements
3/09
Defense Acquisition Training - Improved Statement of Work
5/09
Defense Acquisition Training - Cost Estimating 5/09
Ethics Training 9/09
Federal Appropriations Law Training 11/09
AWARDS / ACCOMPLISHMENTS
Employee of the Month 10/92
Quality Step Increase 2/93
Public Health Service Recognition Award 4/93
Department of Health and Human Services Recognition Award
5/94
Assistant Secretary for Health Special Citation Award
6/94
Special Act / Service Award 5/95
Patriotic Service Award 5/95
Performance Award 6/96
Special Act / Service Award 10/96
Special Act / Service Award 5/97
Special Act / Service Award 10/98
Special Act / Service Award 2/99
Special Act / Service Award 5/99
Special Act / Service Award 7/99
Special Service Act Award 11/99
DHHS Secretary's Award for Distinguished Service 5/00
Quality Step Increase 6/01
Quality Step Increase 12/02
DHHS Secretary's Award for Distinguished Service 1/03
NIDA Director's Award of Merit 6/03
Special Act / Service Award 7/03
Cash Award 7/03
Quality Step Increase 7/04
Cash Award 7/05
Quality Step Increase 5/06
Cash Award 7/06
Cash Award 3/07
Cash Award 8/07
Cash Award 1/08
Employee of the Month 6/08
Cash Award 6/09
Cash Award 1/10
Cash Award 7/10
LANGUANGES / COMPUTER SKILLS
Computer skills: MSWord, MSExcel, MS Power Point, MS Project, MS Outlook,
MS Paint, MS Reference Manager, Navigation Tools via Internet Explorer /
Netscape / Mozilla Firefox, facsimile, and Xerox
English is my first language; however, I speak Armenian with an eighty
percent fluency rate dependent on the dialect.
PUBLICATIONS
POSTER / ABSTRACT
Elkashef A, Fudala P, Gorgon L, Li S, Chiang N, Vocci F. Transdermal
selegiline for the treatment of cocaine dependence: Preliminary analysis,
presented at the College on the Problems of Drug Dependence, Miami Beach,
FL, June 2003.
MANUSCRIPT
Elkashef A, Fudala P, Gorgon L, Li S, Kahn R, Chiang N, Vocci F, Collins J,
Jones K, Boardman K, Sather M. Double-Blind, placebo-controlled trial of
selegiline transdermal system (STS) for the treatment of cocaine dependence
2006. Journal of Drug and Alcohol Dependence, 85 (3): 191-197.
Walsh R, Fudala P, Ling W, Casadonte P, McSherry F, Williford W, Collins J,
Raisch D, Kilby S, Gorgon L, Saxon A, Johnson B, Ordorica P, Malkerneker U,
Elkashef A. A multicenter study of buprenorphine/naloxone for the
treatment of opioid dependence in office-based settings (in press: JAMA)
Kahn, R. Biswas, K, Childress, AR, Shoptaw, S, Fudala, P., Gorgon, L.,
Montoya, I., Collins, J., McSherry, F., Li, SH, Chiang, N., Alathari, H.,
Watson, D., Liberto, J., Beresford, T., Stock, C., Wallace, C., Gruber, V.
Multi-Center Trial of Baclofen for Atstinence Initiation in Cocaine
Dependent Individuals. Journal of Drug and Alcohol Dependence.2009 July 1;
103 (1-2): 59-64.
REFERENCES
Available upon request
Contact this candidate