Veronica Rowell has over 15 years of experience in clinical research, primarily focused in oncology, hematology, and cardiology. She has worked as a site manager, clinical research associate, and senior clinical research associate. Her responsibilities have included managing clinical research staff, ensuring protocol compliance, monitoring studies, and analyzing data. She has a Master's degree in Human Services specializing in marriage and family therapy.

1. VeronicaRowell
Jacksonville, FL
veronicarowell@ymail.com
Cell:904.414.2866
Site Manger areas:
Responsible forthe overall directionandoperationof amulti-physician,endocrine researchcenter.This
includedthe managementof staff,humanresource allocationandjobdevelopment.
• Recruitmentof studiesforthe site basedonstudyprotocolsandsite feasibility
• Qualityassurance of all dataprior to monitor/auditreview
• Specialized in oncology, hematology and cardiovascular research.
Therapeuticareas:
Oncology/SolidTumor:SpecifyIndications: Lungs
Hematology:SpecifyIndications: bloodandbone marrow cells
Cardiovascular/Pulmonary/Respiratory:SpecifyIndications:truncus arteriosus
Pharmacodynamics
Education
August/ 2000-June /2004 Capella University MS/ Human Services specializing in marriage and family
therapy
September/1992-June/ 1997 Troy State University BS/ Sociology
SeniorClinical Research Associate
Jacksonville,FL
SeniorCRA,MS degree inHumanServicesspecializinginmarriage andFamilytherapy,5+yearsof
Clinical Researchexperience,the last3yearsas a Clinical ResearchAssociate.
Work Experience
Contract SeniorClinical ResearchAssociate
Johnson and Johnson
Jacksonville,FL.
Clinical Research Associate

2. Jacksonville,FL
February2014-March 2016
Supervised in providing clinical research in cardiovascular diseases and guided therapeutic decisions in
patients on mechanical ventilation.
Monitoring& site managementof 5BostonScientificNeuromodulationprotocolsforindications
includingmigraine,Parkinson'sdisease(Deepbrainstimulation/DBS)andPainmanagement.
• Performedsite selection,initiation,monitoringandclose-outvisitsinaccordance withcontracted
scope of workand goodclinical practice.
• Providedmonitoringvisitsandsite management
• Administeredprotocol andrelatedstudytrainingtoassignedsitesandestablishregularlinesof
communicationwith sitestomanage ongoingprojectexpectationsandissues.
• Evaluatedthe qualityandintegrityof studysite practicesrelatedtothe properconductof the protocol
and adherence toapplicable regulations.
Hires, trains and evaluates productivity and quality of work of clinical research staff.
• Managedthe progressof assignedstudiesbytrackingregulatorysubmissionsandapprovals,
recruitmentandenrollment,case reportform(CRF) completionandsubmission,anddataquery
generation&resolution.
• Createdandmaintainedappropriatedocumentationregardingsite management,monitoringvisit
findingsandactionplansbysubmittingregularvisitreportsandotherrequiredstudydocumentation.
• Actedas a mentorfornewclinical staff.
• Providedassistance tothe Clinical TeamLeadwithdesignof studytools,documentsandprocesses.
Clinical ResearchAssociate
CNS Healthcare
October/2011 to January/2014
In charge exclusively in clinical oncology research. Responsible for patient recruitment,
screening, and treatment for various studies in Phase I-IV of trial. Acted as a liaison between
pharmaceutical sponsors and medical sites. Attended investigator meetings, monitored drug
accountability, insured adherence to study protocols, and presented data obtained during
research
• Assistwithlaboratoryprocessing,the revisionof labmanuals,andthe preparation,andshippingof
samplesspecificallybutnotlimitedtohematology(Phase II),melanoma,andgastrointestinalcancers.
• Clinical site addition;includingsite selectionandstart-updocumentation,review andnegotiationof
informed consents,budgetandclinicalcontracts,respondingtosite principal investigator,coordinator
and IRB's questionsrelatedtothe studyprotocol andinformedconsent.
• Stimulate andtrackstudyenrollment;includingregularcommunicationwithsite coordinatorsandthe
creation/distributionof bimonthlystudyNewsletters.
• Provide managementwithdetailedreportsof clinical activities,asrequested.
• Act as Clinical Affairsrepresentative,interfacingwithrepresentativesfromkeyfunctional groupssuch
as Research& Development,Manufacturing,Sales,Marketing,RegulatoryAffairs,Legal,Contractsand

3. Data Management.
• Facilitate the preparationof studybudgetandprojectplans.
• Studycleanupandclosure activities.
• Responsible forof datamanagementgroup reviewingclinical data/informationandoversightof data
correction.
• Reviewregulatorydocumentsandensure thatrequiredfilesare maintainedatthe site andin house.
• Contribute inthe preparationof annual,interimandfinal reportsandpresentations.
Conducts quality assurance audits as requested.
• Collaborate withPrincipal Investigators,Clinical Oncologists,Hematologists,Pharmacists,Pharmacy
Techs, Clinical ResearchAssociates,Clinical ResearchAssistants,ClinicNurses,InfusionNurses,and
Phlebotomists. Roomsupportexperience duringFDA audit.
• Assistwithoversightof activitiesperformedbyContractResearchOrganizations.
• Provide workdirectiontoClinical ResearchCoordinators.
• Knowledge of StandardOperatingProcedures(SOPs) andDepartmentOperatingProcedures(DOPs)
• Contribute toongoingSOP/DOPdevelopmentandreview.
• Compilationof source documentationforCECreview of adverse eventsandadjudicationof study
endpoints.
• Performedsite selection,initiation,monitoringandclose-outvisitsinaccordance withcontracted
scope of workand goodclinical practice.
• Providedmonitoringvisitsandsite management
• Assistwithlaboratoryprocessing,the revisionof labmanuals,andthe preparation,andshippingof
samplesspecificallybutnotlimitedtohematology(Phase II),melanoma,andgastrointestinalcancers.
TRAINING & CONFERENCES:
• Patient-Oriented Research
• Good Clinical Practices
• FDA Regulations for Clinical Research (IND/IDE), Informed Consent, Adverse Events
• Data and Safety Monitoring, FDA Audits
• Barnett Educational Seminars
• Surviving FDA inspections
• Developing and Negotiating Study Budgets and Contracts
• EduNeering Compliance Wire Training for Medtronic
• Responsibilities of Clinical Research Monitors
• Good Clinical Practices for New Product Investigations
• Protection of Human Subjects in Clinical Trials
• Clinical Research Process
• Ethics as the Foundation to Clinical Research
• Cardiac Diagnostics & Interventions Conference
Technical Skills

4. •Proficient in CTMS, EDC and eTMF systems.
•TrakWare, Inform, Impact, Medidata
•Proficient in Microsoft Office and Apple Work: Word, Pages, Excel, Numbers, PowerPoint, and Keynote.