Project Manager Quality Assurance
Resume:
KATHY J. BUTLER
********@*****.***
SUMMARY:
. Clinical Research Professional with 15 plus years of experience
including Vendor Management, Project Management, NDA submissions and
ISS (Integrated Summary of Safety/Efficacy).
. Diverse therapeutic experience including CNS, Cardiovascular,
Respiratory and Inpatient Surgery for Phase I-IV clinical studies.
. Managed CNS (Migraine) Phase III/Pivotal trial.
. Completed monitoring visit reports and responsible for all
communications for 27 US sites of Phase III CNS studies.
. Vendor Management including budget, accruals, AP/AR, purchase orders
and all communications.
. Developed and organized the implementation of Phase I (PK) trials.
. DMC/DMSB Project Manager and responsible for Safety/AE/SAE tracking.
. Trainer for Study Coordinator and Clinical Research Associates.
. Knowledgeable in personnel laws including CLEA, OSHA, FDA, IRB and
regulatory and research protocols.
. Authored and submitted abstracts for the AHS and AAN.
. Experienced and knowledgeable with Marketing processes of new clinical
drugs and devices.
. Experienced in medical manager software including Patient Assessments,
Lotus Remote Data Entry, SAS, and Inform.
. Extremely skilled in various clinical testing including:
o Heart Rate Variability Testing Pulse Ox
o Vitals and Blood Pressures, EKG
o 24/48 Halter Monitoring, CPR Telemetry Monitoring
o Pulmonary function testing
o Stress testing
o Allergy testing
o Ophthalmology testing/diseases
. Proficient Phlebotomy Instructor.
RESUME:
PROFESSIONAL EXPERIENCE:
MAP PHARMACEUTICALS, INC., Mountain View, CA March 2007 to May 2012
Clinical Research Consultant (January 2011 - May 2012)
Sr. Principal Clinical Research Associate (March 2007 - January 2011)
. Managed CNS (Migraine) Phase III/Pivotal trial.
. Performed clinical monitoring in compliance with FDA regulations and
all related SOPs.
. Monitored clinical trial visits including evaluation, selection,
initiation, interim and close-out of sites.
. Completed monitoring visit reports and responsible for all
communications for 27 US sites of Phase III CNS studies.
. Vendor Management including budget, accruals, AP/AR, purchase orders
and all communications.
. Coordinated collection of information from investigational sites.
. Coordinated database lock.
. Protocol development.
. Deviation management.
. Lead data manager for asthmatic population, analysis and tracking.
Kathy Butler
Resume, Page Two
(Map Pharmaceuticals Experience, Continued)
. Responsible for electronic data capture in Phase Forward/Inform and
eCRF creation.
. Lead for Development of Source Document/Workbook.
. DMC/DMSB Project Manager and responsible for Safety/AE/SAE tracking.
. Oversaw IP distributions and CSM tasks.
. Reviewed Site Invoices in a timely manner to ensure quick processing
and payment to clinical study sites.
. Monitored for Quality Assurance / temperature excursions at each site.
. Supervised ICF and Protocol creation for Phase III CNS study.
. Co-Managed clinical team to organize successful Study Start-Up of
Phase III CNS trial.
. Provided project support to clinical programs with minimum
supervision.
. Developed DSMB Charter.
. Interfaced with all project/clinical groups and off-site personnel as
needed in support of projects.
. Ensured clinical sites have supplies when needed.
. Generated and managed pre-trial paperwork and interfaced internally to
ensure SOPs were followed.
. Abstract author pulmonary safety.
. CSR-deviation management.
. PAI audit prep.
. Protocol development for pipeline studies.
ROCHE PHARMACEUTICAL RESEARCH COMPANY, Palo Alto, CA January 2006 to
September 2006
Sr. Clinical Research Associate (Contract)
. Developed and organized the implementation of Phase I (PK) trials.
. Identified and evaluated investigator sites.
. Reviewed and developed documents and regulatory files.
. Assisted in writing protocols and informed consents.
. Maintained investigational drug accountability.
. Created clinical reports and departmental SOPs.
. Prepared clinical trial agreements.
. Prepared and implemented draft IND safety, CDC and FDA reports.
. Maintained site budgetary demands and insured processing of payment to
investigator sites.
NOVUM PHARMACEUTICAL RESEARCH COMPANY, Las Vegas, NV May 2005 to
January 2006
Clinical Research Manager (Contract)
. Worked with team on Phase I trials.
. Enrolled subjects into studies as per protocol.
. Worked with source documents and QC of study specific documents.
. Coordinated initiation meetings with staff members.
. Consulted with pharmacy technician for drug handling, dispensing and
dosing times.
. Performed and reviewed EKGs and blood draws.
. Oriented and trained staff.
. Provided QA to ensure accurate data.
. Verified proper enrollment procedures to ensure all subjects met
eligibility requirements.
. Maintained GCP certificate.
UC BERKELEY / CALIFORNIA RESOURCE BOARD, Fresno, CA May 2000 to March
2005
Sr. Clinical Research Manager (Contract)
. Managed and coordinated an asthma environment.
Kathy Butler Resume, Page 3
(UC Berkeley/California Resource Board Experience, Continued)
. Directed the growth of the company through staff training.
. Conducted media and public awareness forums and seminars.
. Directed the daily operations of one clinic, six employees, and eight
physicians.
. Liaison with government agencies, physicians, and state agencies.
. Coordinated data and marketing.
. Assisted in the preparation of regulatory submissions.
. Assisted in development of device labeling documents including
registration, patient guides, and package inserts.
. Provided management and results analysis.
WESTAT RESEARCH CORPORATION, Fresno, CA October 1999 to May 2000
Sr. Research Field Technician (Contract)
. Worked on a contract basis in a temporary/full time position with a
research corporation based in Maryland.
. Worked under direct guidance of the EPA.
. Duties consisted of screening, interviewing candidates, and
implementing patient retention activities.
. Gathered testing information such as:
o Heart rate variability
o Pulse ox
o Blood pressures
EDUCATION:
Clayton College, Birmingham, AL
Bachelor of Science, Health
TRAINING:
. Certified GCP
. Certified Emergency Medical Technician
. Certified Medical Assisting Program
. Cardiac Monitor/Rhythm Technician
COMPUTER SKILLS:
. Experienced in medical manager software, such as Patient Assessments,
Lotus Remote Data Entry, SAS, and Inform.
. Highly experienced in computer programs such as Microsoft Windows XP,
Vista, Microsoft Office (Excel, Word, and PowerPoint), Outlook and WP.
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