1. 14 + yearsclinical researchexperience inaCRO,Pharmaceutical andBiotechsetting.
Throughoutmycareer I've managedoperational of Phase I-IV clinical trials. Ihave workedwithmultiple
departmentleadsandvendorstoidentifyandevaluate study progress andprojectpotential safety,
enrollment,dataissuesthatcouldpotentialaffectthe efficiencyof the study. Ihave vastexperience in
program development andstudyprogression. Myexperience includes PhaseI-IV studies fromSite
Evaluation, RegulatoryDevelopment, Site Selection,SubjectRecruitment, SubjectEnrollment,Data
Collection, andDatabase Lockthroughupuntil FDA Submission.
I’ve workedbothinhouse andremotelywithin large,midsizeandboutique CROs. Ipride myworkas a
detailedandresultorientedCRA conductingClinical Trials,instrumental inriskidentificationand
mitigation,managingandconductingclinical trials,developinginternalandexternalclientrelationships
withthe PIsand site staff.
SPECIALTIES: InHouse and Remote ProjectManagement,LeadCRA,FieldMonitoring. Mentoringjunior
or transitioningteammembers,RiskMitigation,SiteBudgetNegotiation, andCustomerRelations
includingInvestigatorMeetingPresentations includingEDC,IVRS,Lab,IPAccountability,Monitoring
Plan,SAEReportingandRegulatorytraining. I’ve beeninvolvedindeveloping Clinical Operations,
ProcessImprovement Plans,DevelopingProjectSpecificPlansandToolstoassistin projectefficiency.
My responsibilitieshave alsoincludeddeveloping DataManagement/QueryResolution plans,CFR
proficiency, ICH/GCPAdherence alongwith Company andsite SOPAdherence.
GOALS: My career goalsare notonlyto assistand mentormyown teambutto pass my experience and
knowledge alongtootherswithinmycompanyandhelpthemwith reachtheirgoalsas well asensure
our companyas a whole meetsourdeliverables.
THERAPEUTIC EXPERIENCE
+14 yearsof Phase I-IV
• Oncology
o Breast
o Ovarian
o Lung (NSCLC)
o Non-Hodgkin’sLymphoma
o FollicularNon-Hodgkin’sLymphoma
o Renal Cell Carcinoma
o Solid/LiquidTumor
o Pancreatic
o Melanoma
• Cardiovascular

2. o OrthostaticHypotension
• InfectiousDisease
o HIV
o Sepsis
o Anti-Infective
o InfantFluVaccine
• NervousSystem Disorder
o Stroke
o PediatricMigraine
• Endocrine Disorders
o Hypogonadism
• Bloodand LymphaticSystemDisorders
o Hemophilia
• General Disordersand Admin Site Conditions
o PainDevice
• Rheumatologic
o Arthritis
o PsoriaticArthritis
• Immunology
o CommonVariable Immune Deficiency(FactorVIII)
• Ophthalmology
o Wet AMD