Project Manager Clinical
Resume:
Nicole L. Reese, BSN, RN
Villa Hills, Kentucky
EDUCATION: University of Kentucky, Lexington, Kentucky
Bachelor of Science in Nursing, Majored in Nursing,
December 1996
HIGHLIGHTS:
. Twelve years of experience in the pharmaceutical and
contract research industry
. Twelve years of clinical monitoring experience involving
investigational new drugs
. Technologically savvy and proficient with Microsoft
Software and EDC systems
. Diverse therapeutic background
. Largest Workload:
o 4 Protocols
o 16 Sites
o 1 Protocol-Cardiovascular Disease; Phase IV; 3
sites
o 1 Protocol-Cerebral Vascular Accident; Phase
IV; 4 sites
o 1 Protocol-Diabetes Mellitus Type II; Phase
III; 6 sites
o 1 Protocol-Rheumatoid Arthritis; Phase III; 3
sites
THERAPEUTIC
EXPERIENCE:
. Cardiovascular Disease (Phase IV) 6 Years as a CRA
o Coronary Artery Disease
o Hypercholesterolemia
o Hyperlipidemia
. CNS/ Neurology (Phase III-IV) 7 Years as a CRA
o Cerebral Vascular Accident
o Insomnia
o Multiple Sclerosis
. Endocrine/Metabolism (Phase III) 3 Years as a CRA
o Diabetes Type II
o Rheumatoid Arthritis
. Nephrology/Urology (Phase II) 2 Years as a CRA
o Liver Transplant
. Pediatrics (Phase II) 4 Years as a CRA
o Endocrinology
o Vaccine
PROFESSIONAL
EXPERIENCE: RESEARCH PHARMACEUTICAL SERVICES, Fort Washington,
Pennsylvania
August 2006 to July 2009
Regional Clinical Research Associate
. Provided monitoring expertise to clinical study teams
. Total site management of Pharmaceutical Clinical Trials
. Identified clinical investigators for site evaluation
. Conducted site initiation visits
. Conducted site monitoring visits
. Conducted site closure visits
. Attended Investigator Meetings
. Maintained a positive relationship with the investigator
and site personnel to ensure the execution of a clinical
trial in a timely, efficient and effective manner
. Ensured that the site staff conducts the study according
to the Clinical Study Protocol (CSP) and in compliance
with regulatory requirements and Standard Operating
Procedures
. Responsible for the monitoring of clinical trial
activities in compliance with FDA regulations, ICH/GCP
guidelines and company SOPs, to support New Drug
Applications
. Provided project team support in the placement,
implementation, evaluation and conclusion of clinical
studies, as stipulated in the monitoring plans
. Provided responses to findings from Clinical Quality
Assurance audits
. Verified source documents with case report forms
. Verified queries on site with source documents and case
report forms
. Reviewed and collected essential documents
. Performed investigational product accountability and
reconciliation
. Prepared reports for Investigator and Site Evaluations,
Clinical Site Initiation; Clinical Site Monitoring; and
Clinical Site Close-Out
. Identified site issues and initiated corrective actions
when necessary
. Therapeutic areas of experience include Insomnia,
Cardiovascular Disease and Diabetes II
. Phases include III and IV
KFORCE PROFESSIONAL STAFFING, Tampa, Florida
September 2004 to August 2005
Field Clinical Trial Monitor
. Responsible for total Site Management of Pharmaceutical
Clinical Trials
. Responsible for looking into and recruiting sites in our
region
. Assisted in the administration of study budgets
. Monitored Clinical Trials in accordance with Hoffman La-
Roche Standard Operating Procedures, in compliance with
FDA Regulations and ICH/GCP guidelines
. Provided project team support in the placement,
implementation, evaluation and conclusion of clinical
studies, as stipulated in the monitoring plans
. Therapeutic areas of experience include Multiple
Sclerosis in Phase III.
PAREXEL INTERNATIONAL
May 2001 to August 2004
Senior, Lead Clinical Research Associate
. Oversaw the conduct of Phase II clinical trials to
ensure the quality and integrity of data and safe and
proper management of study parameters
. Exercised a leadership role for project activities
related to monitoring functions by interfacing with
clinical investigators and other site personnel in order
to carry out this responsibility
. Served as primary contact for the sponsor as well as the
project team
. Acted as Project Manager, CRA and CRA Assistant
throughout protocols
. Conducted clinical site initiation visits
. Conducted clinical monitoring visits
. Conducted clinical site closure visits
. Built and maintained long-term professional
relationships with clinical investigators
. Identified site needs and provide solutions at important
institutions to facilitate the clinical trial process
. Facilitated subject enrollment as necessary at
responsible sites
. Reviewed case report forms with source documents
. Verified queries on site with case report forms and
source documents
. Ensured clinical study sites are conducting clinical
trials in compliance with the respective protocol, and
applicable ICH/GCP guidelines and regulations
. Performed investigation product accountability and
reconciliation
. Prepared reports within the sponsor timelines for
initiation, monitoring and site closure visits
. Therapeutic areas of experience include pediatric
endocrinology (McCune Albright Syndrome and
Gynecomastia)
MEDPACE, LLC, Cincinnati, Ohio
August 1999 to May 2001, Held the Following Positions:
Lead Clinical Research Associate, August 1999 to May 2001
In addition to the responsibilities listed as a Clinical
Research Associate, also accountable for the following:
. Served as primary contact and resource for other CRAs
and the project team as well as the sponsor
. Responsible for the set-up and maintenance of specific
monitoring tools, scheduling project related meeting and
in-services, composing minutes of such meetings
. Conducted co-monitoring visits as needed
. Contributed and presented at Investigator Meetings
. Trained and mentored new staff
Clinical Research Associate, February 1997 to August 1999
. Monitored Phase III and Phase IV Clinical Research
Studies according to GCP regulations and Medpace
Standard Operating Procedures and Sponsor Standing
Operating Procedures
. Responsible for overall site management for assigned
sites including written and verbal communication,
scheduling of monitoring visits, monitor visit reports
and resolution of queries
. Involved with all aspects of assigned projects
including, but not limited to, attendance to all project
related meetings, preparation of SAE reports and
narratives and review of data edits in preparation for
clean database
. Total site management of Pharmaceutical Clinical Trials
. Identified clinical investigators for site evaluation
. Conducted Site Initiation Visits
. Conducted Site Monitoring Visits
. Conducted Site Closure Visits
. Attended Investigator Meetings
. Maintained a positive relationship with the investigator
and site personnel to ensure the execution of a clinical
trial in a timely, efficient and effective manner
. Ensured that the site staff conducts the study according
to the Clinical Study Protocol (CSP) and in compliance
with regulatory requirements and Standard Operating
Procedures
. Responsible for the monitoring of clinical trial
activities in compliance with FDA regulations, ICH/GCP
guidelines and company SOPs, to support New Drug
Applications
. Provided project team support in the placement,
implementation, evaluation and conclusion of clinical
studies, as stipulated in the monitoring plans
. Provided responses to findings from Clinical Quality
Assurance audits
. Verified source documents with case report forms
. Verified queries on site with source documents and case
report forms
. Reviewed and collect essential documents
. Performed investigational product accountability and
reconciliation
. Prepared reports for Investigator and Site Evaluations,
Clinical Site Initiation; Clinical Site Monitoring; and
Clinical Site Close-Out
. Identified site issues and initiate corrective actions
when necessary
. Therapeutic areas of experience include Rheumatoid
Arthritis, Diabetes II, Cardiovascular Disease
(Hyperlipidemia, Coronary Artery Disease and
Hypercholesterolemia)
. Phases included III and IV
COMPUTER
SKILLS:
. Microsoft Office
o Word
o Excel
o PowerPoint
. EDC systems:
o Inform Phase Forward
o Wyeth proprietary EDC system
TRAINING:
. Advanced Clinical Research Associate Training Course,
Drug Information Association, April 1998
LICENSURE:
. RN, Kentucky License # 1084965
Contact this candidate