1. Name: Laura Butler, MA
Address: 11412 Fox Haven
Charlotte, NC 28277
(917) 774-0555
Labutler1896@aol.com
CURRENT POSITION
Date
(most recent on the top)
Senior Clinical Research Associate 2014 - Present
EDUCATION
Date
UNIVERSITY OF PHOENIX
Master of Arts, Curriculum and Instruction
FAYETTEVILLE UNIVERSITY
Master of Arts, Sociology
MOUNT OLIVE COLLEGE
Bachelor of Science, Recreation/Sport Medicine
FAYETTEVILLE TECH
Associate of Science, Recreation Therapy
Pending
CLINICAL RESEARCH EXPERIENCE
Date
TFS CRO/
Senior Clinical Research Associate/Clinical Team Leader
• Identified, selected, initiated, and closed-out appropriate investigational
sites for clinical studies
• Participated in the site nomination process
• Reviewed records to ensure clinical studies were conducted in compliance
with currently approved protocols, applicable regulations, SOPs, work
instructions, guidelines and/or policies
• Assisted in the trending of monitoring findings – took the lead on resolution
of compliance issues at assigned centers
• Maintained Trial Master File and assisted with routine operational functions
• Mentored CRAs and other study personnel
• Assisted in drafting and developing clinical protocols, Investigator Brochures,
Information/Consent forms, Clinical Study Reports, CRF’s, diary cards,
training materials, and other clinical documents, as required by the project,
including clinical sections of regulatory submissions
• Provided on-site training of investigators and other site personnel
• Developed timelines for implementation of individual studies and clinical
development programs
• Arranged and managed resources to conduct clinical trials
• Assisted with identifying and selecting resource providers and evaluating
these services on an ongoing basis
• Negotiated budgets to ensure required services were contracted as cost-
efficiently as possible; managed budgest and timelines
• Ensured appropriate internal review of contracts and budgets, including
coordinating with other functional areas (e.g., Regulatory Affairs, Program
Management, Legal), as applicable
AKESIS, LLC/
Clinical Trials Manager
01May14 – 01Mar15
03Sept13 - 01Apr14
• Identified, selected, initiated, and closed-out appropriate investigational
sites for clinical studies
• Participated in the site nomination process

2. • Reviewed records to ensure clinical studies were conducted in compliance
with currently approved protocols, applicable regulations, SOPs, work
instructions, guidelines and/or policies
• Assisted in the trending of monitoring findings – took the lead on resolution
of compliance issues at assigned centers
• Maintained Trial Master File and assisted with routine operational functions
• Critically evaluated data for clinical reports
• Mentored CRAs and other study personnel
• Assisted in drafting and developing clinical protocols, Investigator Brochures,
Information/Consent forms, Clinical Study Reports, CRF’s, diary cards,
training materials, and other clinical documents, as required by the project,
including clinical sections of regulatory submissions
• Provided on-site training of investigators and other site personnel
• Developed timelines for implementation of individual studies and clinical
development programs
• Arranged and managed resources to conduct clinical trials
• Assisted with identifying and selecting resource providers and evaluating
these services on an ongoing basis
• Negotiated budgets to ensure required services were contracted as cost-
efficiently as possible; managed budgest and timelines
• Ensured appropriate internal review of contracts and budgets, including
coordinating with other functional areas (e.g., Regulatory Affairs, Program
Management, Legal), as applicable
• Ensured that all tasks contributing to the conduct of a clinical study were
completed as scheduled and as budgeted
• Apprised Managers of progress and of any deviations or other situations as
they arise
• Reviewed deliverables from vendors, including Statistical Analysis Plans,
Data Management Validation Plans, Data Handling Reports, Clinical Study
Reports and Appendices
ICON CLINICAL RESEARCH/
Senior Clinical Research Associate/Clinical Team Leader
• Identified, selected, initiated, and closed-out investigational sites for clinical
studies
• Monitored sites to ensure studies were carried out according to the study
protocol, ICON SOPs/WPs, applicable regulations and the principles of ICH-
GCP
• Provided a benchmark of monitoring competence to inexperienced/less
experienced colleagues; mentored CRAs and other study personnel
• Maintained Trial Master File & assisted with routine operational functions
• Critically evaluated data for clinical reports
• Provided on-site training of investigators and other site personnel
• Developed timelines for implementation of individual studies and over
clinical development programs
• Assisted with identifying and selecting resource providers and evaluating
those services on an ongoing basis
• Negotiated budgets to ensure required services were contracted as cost-
efficiently as possible; managed budgets & timelines
• Ensured appropriate internal review of contracts and budgets, including
coordinating with other functional areas (e.g., Regulatory Affairs, Program
Management, Legal), as applicable
• Assisted in other areas of study management and staff training and
contributed to the review of ICON systems and procedures as appropriate
ReSearch Pharmaceutical Services (RPS)/
Regional Senior Clinical Research Associate
• Monitored (pre-study, initiation, routine, and close-out visits) at investigator
sites for GCP compliance according to the RPS SOPs and/or client guidelines
• Generated study specific documentation including monitoring trip reports,
telephone contact reports, & site correspondence
• Recruited investigators for participation in clinical trials
• Obtained, reviewed for appropriateness, and processed regulatory and
11Oct11 – 03Sept13
06Nov10 – 11Oct11

3. administrative documents from investigator sites
• Resolved queries of CRF data with study sire personnel
• Reviewed tables and listings generated from study data
PHARMANET/
Regional Senior Clinical Research Associate
• Monitored (pre-study, initiation, routine, and close-out visits) at investigator
sites for GCP compliance according to PharmaNet SOPs and/or client
guidelines
• Generated study specific documentation including monitoring trip repots,
telephone contact reports, & site correspondence
• Recruited investigators for participation in clinical trials
• Conducted project feasibility assessments
• Negotiated study budgets with investigators
• Obtained, reviewed for appropriateness, and processed regulatory and
administrative documents from investigator sites
• Reviewed draft protocols for completeness and feasibility. Developed case
report forms for clinical trials
• Presented (e.g., study specific guidelines and procedures, case report forms,
and monitoring conventions) at Investigators’ Meetings
• Prepared and processed Serious Adverse Event (SAE) reports according to
plan
• Prepared project management reports for clients, project personnel, and
PharmaNet management
• Resolved queries of CRF data with study site personnel
• Reviewed tables and listings generated from study data
• Assisted in writing clinical study reports
• Trained junior CRAs on monitoring, internal procedures, and query
resolution
DUKE UNIVERSITY/
Clinical Research Associate
• Qualified, initiated, monitored, and closed out assigned sites
• Inspected the prospective sites, interviewed the principal investigator,
coordinator, and other pertinent personnel to determine if the site meets all
requirements of the study
• Reviewed the protocol, individual responsibilities, and drug accountability
with those involved in the study and answered their questions
• During the monitoring visit, reviewed source documents, CRFs, and informed
consent forms verifying compliance with all protocol requirements
• During the close out visit, reviewed the regulatory document binder and
reconciled it to the sponsor’s study file, shipped study drug for destruction,
collected unused CRFs, collected lab supplies, returned any instruments on
loan to the site, and reviewed federal regulations with the principal
investigator
• Generated visit reports after each visit
• Assisted sites with various problems as they occurred
• Participated in investigator meeting, various study-related meetings and all
CRA training sessions
• Interacted with study sponsor, clinical research organization, principal
investigators and study coordinators when necessary
• Collected, reviewed, recorded and forwarded all regulatory documents
appropriately
• Provided clinical monitoring input for bid proposals and defenses
VIRGINIA COMMONWEATLTH UNIVERSITY/
Clinical Research Coordinator
• Conducted informed consent procedures
• Explained protocol to potential participants; served as contact for study
protocl
01Sept07 – 06Nov10
03Jan07 – 01Sept07
15Aug05 – 15Oct06

4. • Determined eligibility for clinical studies according to the criteria
• Maintained/provided referral sources for those not qualified for study
• Interviewed participants using standardized measures
• Collected data
• Served as liaison between funding sources and IRB
• Maintained study documentation and provided information to PI
• Provided administrative support/coordination for OB/GYN by managing a
variety of project related functions
Refer to Relevant Professional Experience
PHARMACEUTICAL PRODUCT DEVELOPMENT, INC./
Clinical Research Assistant
• Collected, reviewed, and managed the regulatory documents for Phases I-IV
trials
• Assisted sites with various problems as they occurred
• Performed in-house audits of investigator files by identifying discrepancies in
regulatory documents and initiating corrective action
• Supervised and trained new employees in GCPs and SOPs
• Utilized databases for tracking/updating study data
• Generated and distributed various monthly reports
• Participated in various study-related meetings and CRA training sessions
• Interacted with study sponsor, principal investigators and study coordinators
to ensure timely qualification/initiation of study sites
• Collected, reviewed, and managed the regulatory documents for Phases I-IV
trials
ALPHA THERAPEUTIC/
Quality Assurance Specialist
• Qualified and monitored assigned plasma donor centers
• Inspected the prospective sites, interviewed the investigator, coordinator,
and other pertinent personnel to determine if the donor met all
requirements of the center
• Reviewed the individual responsibilities with those involved in the donor
center and answered their questions
• Collected, reviewed, and managed the regulatory documents for center
employees
• Utilized databases for tracking/updating study data
• Responsible for various study-related meetings and all quality processes
with the donor center training sessions
• Interacted with study sponsor, investigators, and coordinators as required
• Performed blood serum analysis
2003 – 2005
02Aug98 – 21Jul02
15Sept97 – 31Jul98
RELEVANT PROFESSIONAL EXPERIENCE
Date
EMPLOYMENT SOURCE/
Employment Services Coordinator
06Jan03 - 15Aug05
• Coordinated work operations and services supporting individuals with
disabilities
• Assisted sites with various problems as they occurred
• Performed in-house audits of investigator files by identifying discrepancies in
regulatory documents and initiating corrective action
• Supervised and trained new employees in GCPs and SOPs
• Utilized databases for tracking/updating study data

5. • Generated and distributed various monthly reports
• Developed, coordinated, and implemented a range of services to include
social/recreational, job preparation, and attainment, and safety net services
for persons receiving services with the Vocational Rehabilitation Department

6. THERAPEUTIC AREA
Date
Refer to Curriculum Vitae Appendix – Therapeutic Experience
COMPUTER SKILLS
Date
MicroSoft Office Suite: Word; Excel; Power Point
Adobe Professional
Electronic Data Capture (EDC) Systems: ORDC, Medidata RAVE, InForm, DataFax,
IVRS
Experienced user of multiple Clinical Trial Management Systems (CTMS)
1993-Present
LANGUAGE QUALIFICATIONS
Date
English (fluent)
Spanish (Immediate)
1976- Present

7. THERAPEUTIC AREA
Date
Refer to Curriculum Vitae Appendix – Therapeutic Experience
COMPUTER SKILLS
Date
MicroSoft Office Suite: Word; Excel; Power Point
Adobe Professional
Electronic Data Capture (EDC) Systems: ORDC, Medidata RAVE, InForm, DataFax,
IVRS
Experienced user of multiple Clinical Trial Management Systems (CTMS)
1993-Present
LANGUAGE QUALIFICATIONS
Date
English (fluent)
Spanish (Immediate)
1976- Present