Project Manager Management
Resume:
Damon
Fletcher
Kansas City, MO *4154
*********@*****.***
Education:
University of Liverpool
Master of Science in Clinical Research Administration
Completions expected July 2012
the Ohio State University
Bachelor of Science in Psychology
December 2005
Professional Experience:
Over five years experience in clinical research. Trial experiences include
cardiac surgery, ophthalmology, infectious disease and Urology. Can travel
100%
Project Manager/CRA
03/15/2010 to Present
Medispec Ltd.
Regulatory Department
. Oversee and mange all the CRA responsibilities, site start-up and
ongoing procedures of the trial
. Successfully ran a phase 1 device study to FDA approval within study
time frame with high quality data and completed the clinical trials
under the proposed budget
. Facilitate communications between sites and Medispec to increase value
propositions to investigators
. Responsible with the site selection process and study start-up for
each site
. Amended the clinical trial protocol as needed
. Trained and re-trained the study staff and clinical sites on the
protocol as needed
. On-site monitoring at the clinical sites for GCP/ICH compliance, data
verifications and submission of CRFs to data management in a adequate
timeframe to avoid "data lock crunch time"
. Generated and resolved queries
. Implemented corrective action plans for sights that were found to not
be GCP compliant.
. Designed source documents and CRFs for clinical sites
. Submission of study results to the FDA
. Submission of all safety findings to the FDA as they arise
. Submission of the PMA and/or IND application to the FDA
. Review and updated the standard operating procedures for the company
as issues arose. Also, consulted with the sites to update SOPs to
reflect the changes in FDA requirements
Sr. Clinical Trials Assistant/In-House CRA (contract through Aerotek)
11/02/09 to 03/15/2010
Quintiles
Clinical Operations
. Assist Clinical Team Lead and CRA's with accurately updating and
maintaining clinical systems that track site compliance and
performance within project timelines
. Collaborate with CTL on the preparation, handling, filing and
archiving of clinical documentation and reports according to the scope
of work and standard operating procedures. Assist in periodic review
of study files for accuracy and completeness.
. Collaborate with CTL on the preparation, handling and distribution of
clinical trial supplies and maintenance of tracking information.
. Assist with tracking and management of Case Report Forms, queries and
clinical data flow.
. Act as central contact for clinical team for designated project
communications, correspondence and associated documentation.
. Perform assigned administrative task to support team members with
clinical trial execution.
Research Coordinator
06/17/2008 to 10/28/2009
Eye Foundation of Kansas City
Research Department
. Assists with investigational study selection and project negotiation,
including initial site/sponsor correspondence, budget preparation,
regulatory document preparations for protocol, informed consent and
appropriate HIPPA inclusions for IRB submission.
. Ongoing management of study review process according to
site/sponsor/IRB guidelines.
. Responsible for patient screening, recruitment, consent process and
enrollment for ongoing clinical research projects, including all
follow up management visits and case report form completion.
. Maintains source documentation and drug/device accountability.
. Conducts staff in-services prior to implementation of new research
trials.
. Coordinate studies in retina and neuro-ophthalmology
. Perform in-house audits on current studies
. Successfully ran multiple multi-center trials in phases 2-4
Clinical Research Coordinator
07/15/2006 to 06/14/2008
Henry Ford Hospital
Department of Ophthalmology
. Assists with investigational study selection and project negotiation,
including initial site/sponsor correspondence, budget preparation,
regulatory document preparations for protocol, informed consent and
appropriate HIPPA inclusions for IRB submission.
. Ongoing management of study review process according to
site/sponsor/IRB guidelines.
. Responsible for patient screening, recruitment, consent process and
enrollment for ongoing clinical research projects, including all
follow up management visits and case report form completion.
. Maintains source documentation and drug/device accountability.
. Conducts staff in-services prior to implementation of new research
trials.
. Conducts self audits for ongoing trials at the site
. Attended grand rounds and continuing education monthly
. Coordinate studies in retina, glaucoma, dry eye and cornea
Ophthalmic Technician
06/2005 to 07/14/2006
Vision Institute of Michigan
. Performed preliminary screening examinations for physician review
including, but not limited to, central and peripheral visual field
tests; ocular motility tests; color vision tests; pharmacological
pupil tests; tonometry, tonography and tensilon tonography tests to
determine intraocular pressure and pupil testing for size, equality
and reaction prior to dilation.
. Examined the cornea, lens and anterior chamber of the eye using a slit
lamp and note variations from normal.
. Measured acuity of patient, with and without glasses, for distance and
near vision; obtained optical and lensometry measurements to determine
lens prescription and corrected acuity problems; recorded findings on
patient chart.
. Directed the flow of patients examined by an Eye Center physician;
obtained medical and personal data for patient charts; screened
patients for conditions excluding ocular examination; arranged for
laboratory and other tests, ophthalmic photography, outpatient studies
and patient admissions and surgery as requested by physician;
alleviated patient and family concerns by explaining diagnostic
procedures and method of treatment.
. Sterilized and set up instruments for ophthalmic surgical procedures;
assisted with minor office surgery, laser treatments and operating
room surgery as required.
Involvement:
. Big Brothers Big Sisters of District of Columbia
. Pi Kappa Alpha Fraternity
. Omega Delta Kappa Greek honor society
. Ohio State Alumni Association
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