CURRICULUM VITAE

Cynthia K. Sylvester
966 Mt. Pleasant Ave
Columbus OH, 43201
Office Phone: 614-298-9058
Cell Phone: 614-783-8719
Email: cs50bb28@westpost.net
Personal Biography
Possess over 24 years of clinical research experience in the pharmaceutical and
CRO industries including pre-clinical pharmacology/toxicology, clinical site mon
itoring, field management and project management experience. Responsible for pr
oviding direct management to Clinical Research Associates (CRAs) (8-10 CRAs, 1-3
protocols) and Clinical Trial Specialist (CTS) (4-6 CTSs, 1-2 protocols). Expe
rienced in clinical Phases I-IV. Areas of therapeutic experience include cardiov
ascular, infectious disease, endocrinology, nephrology, oncology, gastrointestin
al, central nervous system, and vaccine-related trials.
Education
The Ohio State University, Bachelor of Science Nursing
Columbus State Community College, Associate Degree Candidate, Animal Health Scie
nce

Working Experience and Career History

From - To Title & Position Summary Company
1998 - 3/31/10
Project Specialist (Regional Manager)/Lead CRA 1998- 3/31/10
* Develop and maintain knowledge of the protocol(s) and the contract requirement
s related to field monitoring for assigned protocol/s.
* May assume responsibility for the development of the protocol-specific Study M
onitoring Plan and tools in collaboration with members of the project team.
* Liaise with Clinical Trial Specialist/Project Manager(s) to ensure adequate CR
A support for projects(s)
* Participate in the review of protocols, Case Report Forms (CRFs), informed con
sents, and other study documentation, study processes and tools.
* Produce regular status reports to track Field Operations' deliverables (i.e.,
site visits, telephone contacts, trip reports and follow-up letters, CRF monitor
ing and retrieval, budget, etc).
* Conduct on-site CRA assessment visits and/or perform co-monitoring visits
* Perform annual CRA performance evaluations through established performance met
rics in order to ensure sponsor /CRO standards are met. Generate performance app
raisal reports and conduct appraisal with CRA.
* Provide on-site training sessions to new field monitors or study site personne
l as needed, inclusive of maintaining training documentation records
* Answer routine written and telephone inquiries from personnel at study sites o
r the field monitoring team.
* Prepare for and participate in external and internal meetings as required. Pr
esent at Investigator/Coordinator/Monitor Meetings as requested.
* Participate in Project Team teleconferences.
* Ensure continuous adequacy of CRA resources and performance.
* Review CRA timesheets to assess resource utilization and review expenses to en
sure compliance with sponsor/CRO budget. Approve paid-time-off.
* Review site visit reports and follow-up letters to ensure the quality oft he r
eports and to identify study and/or site related issues requiring attention or f
ollow-up.
* Oversee process for project assigned CRA's response and follow-up to QA Field
Audits
Project Manager 09/01/05 - 10/31/08
* Manage execution of project(s), in accordance with contractual obligations, ac
ross all disciplines (e.g., Regulatory Affairs/Operations, Site Monitoring, Clin
ical Management, Data Services, etc.) and provide accurate weekly updates on pro
gress within each discipline.
* Manage all aspects of projects using Pierrel's CTMS software
* Manage project team as a cohesive unit of line representatives.
* Manage project team meetings efficiently. Meetings are to be conducted on a r
egular basis (e.g., bi-monthly) with an agenda issued prior to the meeting and m
inutes, with assigned and timed action items, issued promptly after the meeting.
* Ensure all project functions are conducted in accordance with Pierrel SOPs (or
applicable Sponsor SOPs) and all applicable regulatory requirements.
* Primary Pierrel interface with sponsors on day-to-day basis.
* Conduct QC review of all reports sent to Sponsor(s) from the various project t
eam members.
* Manage contract deliverables. Collaborate with Business Development in prepar
ing Change(s) of Scope when necessary.
* Manage project finances including monthly reconciliation of Finance/Project re
ports, assessing spend vs. budget by discipline and milestone status.
* Review and approve monthly invoices to Sponsor(s).
* Review final draft documents including, but not limited to, protocols, amendme
nts, final study reports, study monitoring plans, data management plans, and oth
er project-specific guidelines.
* Manage vendors (labs, packaging, etc.) efficiently.
* Lead and manage all aspects of Investigator/Coordinator meetings.
* Provide project-specific training to appropriate Pierrel staff and/or Investig
ator site staff.
* Develop and maintain Project Team Membership List(s) in accordance with SOPs
* Develop and maintain Project Binder of project-specific guidelines.
* Provide input to the annual performance appraisal for each member of the proje
ct team.
* Assist Business Development in the development of proposals and participate in
Business Development presentations for new business, as applicable.
Pierrel Research USA (formerly Encorium Group, Inc.)
Wayne, PA
1997 - 1998
Clinical Research Manager, Independent Consultant
Managed clinical trial sites involving an alkalating agent in the treatment of b
reast cancer to ensure adherence with sponsor protocol requirements, GCP guideli
nes, and FDA regulations. Roxane Laboratories
Columbus, OH

1996 - 1997
Clinical Research Associate
Monitored Phase III clinical research projects in Parkinson's Disease, Thrombopr
ophylaxis in THR surgery, Acute Sinusitis, Pneumonia, and Complicated Skin and S
oft Tissue Infections to ensure adherence with sponsor protocol requirements, GC
P guidelines, and FDA regulations. Independent Consultant

1995 - 1996
Clinical Research Associate II
Recruited, initiated, monitored and coordinated activities for over 40 investiga
tional study sites for four phase III clinical trials with a low molecular weigh
t heparin (LMWH) in cardiovascular, orthopedic, and high risk abdominal surgery
indications. Pharmacia & Upjohn
Dublin, OH
1984 - 1995
Medical Research Associate II 1993 - 1995
Managed, monitored and coordinated all aspects of three phase III clinical trial
s in 19 investigational study sites with a LMWH in orthopedic and cardiovascular
indications.
Clinical Data Analyst 1990 - 1993
Responsible for the collection and review of data from over 100 U.S. and Europea
n study sites for phase II and III breast cancer trials.
Pharmacology/Toxicology Research Technician 1984 - 1990
Directed or assisted in the conduct of multiple pre-clinical acute, sub-acute, c
hronic and carcinogenic toxicity animal studies, including drug preparations and
administration, monitoring, data retrieval, surgical interventions, terminal ne
cropsies, histologic techniques, and hematology and chemistry procedures. Adria
Laboratories/Pharmacia
Dublin, OH

Language Skills
Language Fluent Good Basics
English Yes
Computer Skills
* Microsoft Office Software, including Word, Excel, and Powerpoint. Electronic D
ata Capture systems: iDataFax, IMPACT
Memberships
* Associates of Clinical Research Professionals (ACRP)