[pic] June

**, ****

Alease Winchester, BSN, MS

Clinical Research Associate

Norristown, Pennsylvania.

EDUCATION: Widener University, Chester, PA

Bachelor of Science in Nursing, 1983-1987

Eastern College, Radnor PA

Masters of Science-Healthcare Administration,

1990-1992

WORK EXPERIENCE:

June 2010- Research Pharmacuetical Services, Inc., Fort

present Washington, PA

In-House Clinical Research Associate

Conduct study start-up activities including

feasibility and telephone screening interviews

Develop the Informed Consent Form

Assist with Protocol and Case Report Form (CRF)

review

Site Management; continuous contact with the sites

to discuss study progress, issues, concerns, etc.

Negotiate Investigator Grants

Assist in the planning of the Investigator Meeting

Assist in the development of study manuals,

annotated CRF's, monitoring conventions, tracking

forms, site study tools, etc.

Coordinate with the regional CRA's the timely

shipment if clinical supplies and study drug to

sites

Maintain tracking records

Communicate site study issues, concerns, and

progress to Project Manager.

July 2008-May Research Pharmacuetical Services, Inc., Fort

2010 Washington, PA

Clinical Research Associate

Responsible for study start-up activities including

feasibility, researching and contacting potential

investigators

Work with proposed Vendors to get sites the

equipment/supplies needed

Prepare the Informed Consent Form (ICF)

Review and approve Monitoring Reports as well as

ICF's and provide feedback to the regional monitors

and study sites

Continuous contact with the sites to discuss study

progress, issues concerns, etc

Continuous contact with the regional monitors via

weekly teleconferences, telephone calls, etc.

Develop and provide input for the monthly Newsletter

Recruitment telephone calls to encourage the sites

and to ask about concerns/issues etc.

Provides close oversite of the CRO/Vendors to ensure

successful completion of the study

Track the progress of ongoing clinical trials

Ensure that timelines are being met, changed exceeded

as needed

April 2006- June Research Pharmaceutical Services, Inc., Fort

2008 Washington, PA

Clinical Research Associate

Site Management: Responsible for 25 sites; start-up

activities i.e. the collection of regulatory

documents etc.

Maintain study documents through the Sponsor's

in-house system i.e. IMPACT, E-room

Recruitment: Monthly telephone calls to encourage the

sites, offer recruitment materials, issues/problems

etc.

November Research Pharmaceutical Services, Inc., Plymouth

2004-April 2006 Meeting, PA

Clinical Research Associate

Site Management: Study start-up activities

Collect and enter study documents into the Sponsor's

in-house system

Recruitment ( encourage existing sites as well as

identifying potential sites

Maintain excel spreadsheet with the status of new

sites weekly

Review and approve Informed Consent Forms and

Monitoring reports with feedback to the regional

monitors and study sites

Continuous contact with site personnel to ensure

protocol and GCP compliance

April 2002-May Research Pharmaceutical Services, Inc., Plymouth

2004 Meeting, PA

Clinical Research Associate

Maintain study information via IMPACT (recruitment,

investigator addresses, IRB expiratory dates)

Responsible for ensuring the Investigator safety

letters were sent to all study sites

Review Pre-Study and Monitoring Visit Reports while

receiving and providing feedback from the CRO

Maintain and track SAE Reports and reconcile with the

CRO database

Maintain and update the Real time Laboratory data

Spreadsheet and coordinate delivery of the

spreadsheet with my Global counterpart

Order study drug via the Sponsor's in-house system

April 1998-April Wyeth-Ayerst Pharmaceutical Company, Radnor, PA

2002 Safety Surveillance Reviewer

Process spontaneous and serious adverse events

through the Sponsor's in-house system

Process literature and post-marketing adverse events

via case assessment and case review through the

Sponsor's in-house system

Preparation and review of Periodic Safety Reports for

submission to the FDA

Respond and answer safety queries

November Wyeth-Ayerst Pharmaceutical Company, Radnor, PA

1994-May 1998 Clinical Scientist II

Site Management: for all projects; study start-up

activities (collect and receive documents etc.

Study Initiation Visits; train, direct and supervise

site personnel to all requirements of the clinical

trial including the collection of adverse event

reports, etc.

Writing/development of clinical protocols

Negotiate contracts and budgets

Critical analysis of Data Processing Reports

Manage support staff

November 1993- Wyndemere Temporary Agency, Philadelphia, PA

November 1994 Clinical Data Reviewer

Review of case report forms for completeness,

consistency and accuracy

August Sacred Heart Hospital, Norristown, PA

1987-November Staff Nurse; Medicine/Surgery and Intensive Care Unit

1993

THERAPEUTIC AREA Cardiology: Hypertension, Anti-thrombotic, Hormone

EXPERIENCE replacement therapy

CNS: Schizophrenia, Traumatic Brain Injury and Shift

work Disorder

Infectious disease: generalized infection

CURRENT Registered Nurse: License Number RN293345L

LICENSURE &

CERTIFICATIONS

COMPUTER SKILLS EDC (Phoenix Data Systems), Word, Excel, and Outlook

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