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Cassandra Foster, CCRP
6531 Pressed Gentian Columbia, MD 21045
443-878-6724, cassicroix@yahoo.com
1 | P a g e
Overview: Dedicated and self-motivated clinical research professional with extensive hands-on experience in:
clinical research management, study participant recruitment, accurate and compliant consent process
management, policy analysis, project management, working within a research organization, general office &
database administration, foreign travel and public relations.
Summary of Qualifications
 SkilledinProtocol development ensuringcompliance withall internal andexternal policiesandproceduresthat
governinstitutional researchefforts.
 Managed clinical trial administration supportingPrincipal Investigators,Physicians andBiostatisticiansorganizing
the researchobjectives involvingseveralInstitutional Review Boards,UniversityClinical Research Centers,
UniversityResearchReview Committeesandthe National Institutes of Health.
 Establishedpolicies andprocessessupportingcomplex research programs partneringwithvariousproject
stakeholders.Identifiedissuesrequiringan interventionandrecommendedatailoredqualityimprovement
processes. Identifiedtrends,discrepancies,andsituations needingfurtheranalysisbyPrincipal Investigators,
Physicians,Biostatisticians,StudyMonitorsand/orAuditors. Developedandmaintainedthe necessarylegaland
regulatoryprocessesandagreementsrelatedto the collection,storage andretrieval of specimens andrelated
phenotype data.
 Streamlinedresearchrelatedadministration,managementandregulatoryprocesses throughDataUsage
Agreements,Material TransferAgreements,andCertificatesof Confidentiality. Manageddataadministering
dbGaP (National Institutesof HealthDatabase of GenotypesandPhenotypes), the publicrepositoryfor
individual-level phenotype,genotype andsequence data. Regulatedthe properexchange of de-identifieddata
(bio-bankdata,genetic/molecularprofiles,andclinical phenotypes) andreinforcedthe HealthInsurance
PortabilityandAccountabilityActof 1996 (HIPAA) thatcoversprotectedhealthinformationwithinthe electronic
medical recordsystem(s).
 Documentedresearchrelatedobservationsandmaintaineddetailednotes.Collected,labeledandorganized
data sourcesfor individual protocols.Revieweddatawithresearch departments, preparingandpresentinga
summarywithleadershipteam members.Providedregularupdatestothe programteamsduringteam
meetings.Preparedandpresentedreportsandsummariesasneeded,andparticipatedinthe publicationand
presentationof the program’sresults. Developed,integratedandcollectedinformation usedtoproduce
workflowcharts andorganizational layoutsasitrelatedtohumansubjectsresearch.
 Strongcommunicationskills,adeptatdevelopingandmaintainingdetailedadministrationandprocedural
processesthatreduce redundancy,improveaccuracy& efficacyandachieve the qualitativeresearchobjectives.
 Dutifully evaluatedgrantobjectivesand conducteddetailedresearchassessmentsto determine the structures
and needsforoperational assistance.Establishedcriteriaforstudyprotocols,includingthe developmentof
StandardOperatingProcedures(SOP)andfacilitatedthe planningandimplementationof InstitutionalReview
Board (IRB) research,developmentandrenewalactivities identifyingissuesandrecommendedsolutionsto
assure compliance. Createdprojectreportsonproductionanddeviationsof establishedobjectivesforan
equitable outcome.
Cassandra Foster, CCRP
6531 Pressed Gentian Columbia, MD 21045
443-878-6724, cassicroix@yahoo.com
2 | P a g e
Program Administrator July 2016 to September 2016
Johns Hopkins University - Baltimore, MD: School of Medicine, Department of Medicine and Division of
Infectious Disease
 Coordinatedinternational multi-sitehumansubjectdrugprotocolsassistingwiththe JHUadministrative
processesforTB and HIV studies
Research Data Coordinator July 2008 to July 2016
Johns Hopkins University - Baltimore, MD: School of Medicine, Department of Medicine and Division of
Asthma and Clinical Immunology
 Coordinatednational andinternational multi-sitepopulation-basedstudiesusing22active Johns Hopkins
Universityprotocols
 Responsible forestablishingrecruitmentbudgetsbasedonthe numberof neededsubjectsandadvertisements
 Recruitedandconductedinitial screeningof 350+ subjects
 ImplementedStandardOperatingProcedures (SOP)
 Developedinclusion/exclusioncriteriareviews
 Operated underGoodClinical Practices (GCP) procedures
 Reviewedanddevelopedinformed consentforms
 Createdandexecuted 22 studyprotocolsthatcompliedwithJohnHopkins University’s Internal ReviewBoard
regulations
 Responsible forthe appropriate handlingof ProtectedHealthInformation (PHI)
Data Manager February 2007 to July 2008
Johns Hopkins University - Baltimore, MD: School of Medicine, Department of Medicine and Division of
Asthma and Clinical Immunology
 Validateddata,ensuringthe integrityandqualityforbothanalogand ElectronicData Capture (EDC)
 Contractedand outsourcedlarge scale dataentryprojects (275+ documents)
 Assuredappropriate handlingof ProtectedHealthInformation(PHI)
 Assuredproperdocumentstorage of data
 Responsible fordbGaP reportsandsubmissions
 PreparedreportsforData AnalysisCore (DAC)
 Preparedreportsforthe Data and SafetyMonitoringBoard
Sr. Medical Office Coordinator December 2005 to February 2007
Johns Hopkins University - Baltimore, MD: School of Medicine and Department of Neurology
 Managed clinical researchandclinical provider’soffice
 Promotedgoodpatientrelationsandscheduled timely outpatientcare
 Scheduledlaboratorytests andmedicalexaminations
 Maintainedfamiliaritywithvarioustypesof medical insurance benefitsandrules
 Establishedthe pre-certificationrequirementsand3rd
party paymentplans forall patientinsurance companies
 Advisedpatientsof feesforcare andguided themtoappropriate resourcesforfurtherassistance
Cassandra Foster, CCRP
6531 Pressed Gentian Columbia, MD 21045
443-878-6724, cassicroix@yahoo.com
3 | P a g e
Editorial Assistant March 2003 to December 2005
The National Academy of Sciences - Washington, DC
 Servedasliaisontoeditors,authors, andreviewersformultidisciplinaryscientificjournal publications
 Drafted,formatted andeditedmaterialsincludingweeklyreportsrelative tomanuscriptsubmissions,staff
productivityandtimeliness
 MaintainedeffectivecommunicationswithProceedingsof the National Academyof Sciences (PNAS)Editorial
Board Members
 AttendedconferencesasPNASrepresentative
 Managed the paperlesspeer-review processformanuscriptpublication
 Updatedtrackingsystems(OLS,MTS, and E-Journal Press)
Editorial Assistant September 2000 to February 2003
American Geophysical Union - Washington, DC
 Coordinatedpaperlesselectronicpeerreview processforscientificjournal
 Actedas liaisontoauthors,reviewersandeditors
 Lead developmentof aweb-basedpeerreview system
 Draftedtrainingmanualsforeditorial supportstaff
 Responsible fordevelopingandtrainingstaff indepartmentalprocedures
Education
Bradford College (Liberal Arts classes)
Certifications and Professional Development
 SoCRA - Clinical ResearchProfessionalCertification,August2013
 CommunityCollege of Baltimore County –Certificate of HealthInformationTechnology - EHR SpecialistHITECH
Grant Training,October2012
 JohnsHopkinsEducationandResearchCenterforOccupational SafetyandHealth - CertifiedNIOSHSpirometry,
October2010
 AmericanAcademyof PhlebotomyTechnicians - CertifiedPhlebotomist,January2009
 JohnsHopkinsUniversitySchool of Medicine - DOT/IATA - BiohazardShipping, March2008
 JohnsHopkinsUniversitySchoolsof Nursing,Medicine,andPublicHealth - Fundamentalsforthe Research
Coordinator, October2007
 JohnsHopkinsUniversity - HIPAA Compliance Professional DevelopmentSeries,January2006
Computer Skills
MicrosoftOffice:Word,Excel andAccess.Database design andDatabase management&administration(BCPlatforms,
Database of GenotypesandPhenotypes dbGaP)
Cassandra Foster, CCRP
6531 Pressed Gentian Columbia, MD 21045
443-878-6724, cassicroix@yahoo.com
4 | P a g e
Publications and Papers
1. A continuum of admixture in the Western Hemisphere revealedby the African Diaspora genome (Mathias et
al.) Nature Communications Oct. 2016 Article number: 12522 (2016) doi:10.1038/ncomms12522.
2. Co-associationsbetweenIL-10polymorphisms,IL-10production,helminthinfectionandasthma/wheeze inan
urban tropical populationinBrazil. FigueiredoCA,BarretoML, Alcantara-NevesNM,RodriguesLC,CooperPJ,
Cruz AA, Pontes-de-CarvalhoLC,Lemaire DC,dosSantosCosta R, AmorimLD,Vergara C,RafaelsN,Gao L, Foster
C, Campbell M,MathiasRA, BarnesKC: J AllergyClinImmunol.2013 Jun;131(6):1683-90. doi:
10.1016/j.jaci.2012.10.043. Epub 2012 Dec 28. Erratum in:J AllergyClinImmunol.2013 Oct;132(4):1015.
3. A genome-wideassociationstudyonAfrican-ancestrypopulationsforasthma. MathiasRA,Grant AV,RafaelsN,
Hand T, Gao L, VergaraC,Tsai YJ, Yang M, Campbell M,FosterC,Gao P, TogiasA, Hansel NN,Diette G,Adkinson
NF,Liu MC, Faruque M, DunstonGM, WatsonHR, BrackenMB, Hoh J, Maul P,Maul T, JedlickaAE,MurrayT,
Hetmanski JB,AshworthR,OngacoCM, HetrickKN,DohenyKF,PughEW, Rotimi CN,FordJ, Eng C, Burchard EG,
SleimanPM,HakonarsonH, FornoE, Raby BA,WeissST, Scott AF,KabeschM, LiangL, AbecasisG,MoffattMF,
CooksonWO,Ruczinski I,BeatyTH, BarnesKC: J AllergyClinImmunol.2010 Feb;125(2):336-346.e4. doi:
10.1016/j.jaci.2009.08.031. Epub 2009 Nov11.
4. Africanancestryisa risk factorfor asthma andhightotal IgE levelsinAfricanadmixedpopulations. VergaraC,
Murray T, RafaelsN,LewisR,Campbell M,FosterC,Gao L, Faruque M, OliveiraRR,CarvalhoE,AraujoMI, Cruz
AA,WatsonH, Mercado D, Knight-MaddenJ,Ruczinski I,DunstonG, Ford J,CaraballoL, BeatyTH, Mathias RA,
BarnesKC: GenetEpidemiol.2013 May;37(4):393-401. doi:10.1002/gepi.21702. Epub 2013 Apr2.
5. 2015 PosterPresentationentitled“Anapproachforattainingdocumentsconsistentwith45CFR Part 46
researchinvolvinghumanparticipantsandthe developmentof consortiumwaiverandumbrellaprotocol and
Certificatesof Confidentialityforthe ConsortiumonAsthmaamongAfrican-ancestryPopulationsinthe
Americas”(CAAPA JohnsHopkinsDepartmentof Medicine Research Retreat)
6. 2009 AmericanAcademyof Allergy,AsthmaandImmunologyOral presenteronthe topic“correlatingasthma
severitytolungfunctiontestingratios(FEV1/FVC)”
7. 2009 PosterPresentationentitled“DoesFEV1/FVCCorrelatewithAsthmaSeverityScore inMonitoringAsthma
Control?”JohnsHopkinsDepartmentof MedicineResearchRetreat:“New ModelsforScientificInvestigationat
AcademicMedical Centers"
Awards
Certificate of Appreciation:Service Excellence (JohnsHopkins University),May2006
Committees and Memberships
Member- AmericanAcademyof Allergy,Asthma&Immunology(AAAAI)
Member- CAAPA Phenotype HarmonizationGrouphttps://hopkinspcc.org/caapa/
Cassandra Foster, CCRP
6531 Pressed Gentian Columbia, MD 21045
443-878-6724, cassicroix@yahoo.com
5 | P a g e
References
Kathleen Barnes, PhD
kathleen.barnes@ucdenver.edu
303-724-9734
Nicholas Rafaels, MS
nicholas.rafaels@ucdenver.edu
303-724-9918
Candelaria Coggiano MD-PhD
Candelaria.Coggiano@jhmi.edu
410-502-3717
Victor Ortega, MD
vortega@wakehealth.edu
336-716-4649
Judith Carrithers, J.D.
jcarrit1@jhmi.edu
443-287-0204

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Clinical Research Professional Resume

  • 1. Cassandra Foster, CCRP 6531 Pressed Gentian Columbia, MD 21045 443-878-6724, cassicroix@yahoo.com 1 | P a g e Overview: Dedicated and self-motivated clinical research professional with extensive hands-on experience in: clinical research management, study participant recruitment, accurate and compliant consent process management, policy analysis, project management, working within a research organization, general office & database administration, foreign travel and public relations. Summary of Qualifications  SkilledinProtocol development ensuringcompliance withall internal andexternal policiesandproceduresthat governinstitutional researchefforts.  Managed clinical trial administration supportingPrincipal Investigators,Physicians andBiostatisticiansorganizing the researchobjectives involvingseveralInstitutional Review Boards,UniversityClinical Research Centers, UniversityResearchReview Committeesandthe National Institutes of Health.  Establishedpolicies andprocessessupportingcomplex research programs partneringwithvariousproject stakeholders.Identifiedissuesrequiringan interventionandrecommendedatailoredqualityimprovement processes. Identifiedtrends,discrepancies,andsituations needingfurtheranalysisbyPrincipal Investigators, Physicians,Biostatisticians,StudyMonitorsand/orAuditors. Developedandmaintainedthe necessarylegaland regulatoryprocessesandagreementsrelatedto the collection,storage andretrieval of specimens andrelated phenotype data.  Streamlinedresearchrelatedadministration,managementandregulatoryprocesses throughDataUsage Agreements,Material TransferAgreements,andCertificatesof Confidentiality. Manageddataadministering dbGaP (National Institutesof HealthDatabase of GenotypesandPhenotypes), the publicrepositoryfor individual-level phenotype,genotype andsequence data. Regulatedthe properexchange of de-identifieddata (bio-bankdata,genetic/molecularprofiles,andclinical phenotypes) andreinforcedthe HealthInsurance PortabilityandAccountabilityActof 1996 (HIPAA) thatcoversprotectedhealthinformationwithinthe electronic medical recordsystem(s).  Documentedresearchrelatedobservationsandmaintaineddetailednotes.Collected,labeledandorganized data sourcesfor individual protocols.Revieweddatawithresearch departments, preparingandpresentinga summarywithleadershipteam members.Providedregularupdatestothe programteamsduringteam meetings.Preparedandpresentedreportsandsummariesasneeded,andparticipatedinthe publicationand presentationof the program’sresults. Developed,integratedandcollectedinformation usedtoproduce workflowcharts andorganizational layoutsasitrelatedtohumansubjectsresearch.  Strongcommunicationskills,adeptatdevelopingandmaintainingdetailedadministrationandprocedural processesthatreduce redundancy,improveaccuracy& efficacyandachieve the qualitativeresearchobjectives.  Dutifully evaluatedgrantobjectivesand conducteddetailedresearchassessmentsto determine the structures and needsforoperational assistance.Establishedcriteriaforstudyprotocols,includingthe developmentof StandardOperatingProcedures(SOP)andfacilitatedthe planningandimplementationof InstitutionalReview Board (IRB) research,developmentandrenewalactivities identifyingissuesandrecommendedsolutionsto assure compliance. Createdprojectreportsonproductionanddeviationsof establishedobjectivesforan equitable outcome.
  • 2. Cassandra Foster, CCRP 6531 Pressed Gentian Columbia, MD 21045 443-878-6724, cassicroix@yahoo.com 2 | P a g e Program Administrator July 2016 to September 2016 Johns Hopkins University - Baltimore, MD: School of Medicine, Department of Medicine and Division of Infectious Disease  Coordinatedinternational multi-sitehumansubjectdrugprotocolsassistingwiththe JHUadministrative processesforTB and HIV studies Research Data Coordinator July 2008 to July 2016 Johns Hopkins University - Baltimore, MD: School of Medicine, Department of Medicine and Division of Asthma and Clinical Immunology  Coordinatednational andinternational multi-sitepopulation-basedstudiesusing22active Johns Hopkins Universityprotocols  Responsible forestablishingrecruitmentbudgetsbasedonthe numberof neededsubjectsandadvertisements  Recruitedandconductedinitial screeningof 350+ subjects  ImplementedStandardOperatingProcedures (SOP)  Developedinclusion/exclusioncriteriareviews  Operated underGoodClinical Practices (GCP) procedures  Reviewedanddevelopedinformed consentforms  Createdandexecuted 22 studyprotocolsthatcompliedwithJohnHopkins University’s Internal ReviewBoard regulations  Responsible forthe appropriate handlingof ProtectedHealthInformation (PHI) Data Manager February 2007 to July 2008 Johns Hopkins University - Baltimore, MD: School of Medicine, Department of Medicine and Division of Asthma and Clinical Immunology  Validateddata,ensuringthe integrityandqualityforbothanalogand ElectronicData Capture (EDC)  Contractedand outsourcedlarge scale dataentryprojects (275+ documents)  Assuredappropriate handlingof ProtectedHealthInformation(PHI)  Assuredproperdocumentstorage of data  Responsible fordbGaP reportsandsubmissions  PreparedreportsforData AnalysisCore (DAC)  Preparedreportsforthe Data and SafetyMonitoringBoard Sr. Medical Office Coordinator December 2005 to February 2007 Johns Hopkins University - Baltimore, MD: School of Medicine and Department of Neurology  Managed clinical researchandclinical provider’soffice  Promotedgoodpatientrelationsandscheduled timely outpatientcare  Scheduledlaboratorytests andmedicalexaminations  Maintainedfamiliaritywithvarioustypesof medical insurance benefitsandrules  Establishedthe pre-certificationrequirementsand3rd party paymentplans forall patientinsurance companies  Advisedpatientsof feesforcare andguided themtoappropriate resourcesforfurtherassistance
  • 3. Cassandra Foster, CCRP 6531 Pressed Gentian Columbia, MD 21045 443-878-6724, cassicroix@yahoo.com 3 | P a g e Editorial Assistant March 2003 to December 2005 The National Academy of Sciences - Washington, DC  Servedasliaisontoeditors,authors, andreviewersformultidisciplinaryscientificjournal publications  Drafted,formatted andeditedmaterialsincludingweeklyreportsrelative tomanuscriptsubmissions,staff productivityandtimeliness  MaintainedeffectivecommunicationswithProceedingsof the National Academyof Sciences (PNAS)Editorial Board Members  AttendedconferencesasPNASrepresentative  Managed the paperlesspeer-review processformanuscriptpublication  Updatedtrackingsystems(OLS,MTS, and E-Journal Press) Editorial Assistant September 2000 to February 2003 American Geophysical Union - Washington, DC  Coordinatedpaperlesselectronicpeerreview processforscientificjournal  Actedas liaisontoauthors,reviewersandeditors  Lead developmentof aweb-basedpeerreview system  Draftedtrainingmanualsforeditorial supportstaff  Responsible fordevelopingandtrainingstaff indepartmentalprocedures Education Bradford College (Liberal Arts classes) Certifications and Professional Development  SoCRA - Clinical ResearchProfessionalCertification,August2013  CommunityCollege of Baltimore County –Certificate of HealthInformationTechnology - EHR SpecialistHITECH Grant Training,October2012  JohnsHopkinsEducationandResearchCenterforOccupational SafetyandHealth - CertifiedNIOSHSpirometry, October2010  AmericanAcademyof PhlebotomyTechnicians - CertifiedPhlebotomist,January2009  JohnsHopkinsUniversitySchool of Medicine - DOT/IATA - BiohazardShipping, March2008  JohnsHopkinsUniversitySchoolsof Nursing,Medicine,andPublicHealth - Fundamentalsforthe Research Coordinator, October2007  JohnsHopkinsUniversity - HIPAA Compliance Professional DevelopmentSeries,January2006 Computer Skills MicrosoftOffice:Word,Excel andAccess.Database design andDatabase management&administration(BCPlatforms, Database of GenotypesandPhenotypes dbGaP)
  • 4. Cassandra Foster, CCRP 6531 Pressed Gentian Columbia, MD 21045 443-878-6724, cassicroix@yahoo.com 4 | P a g e Publications and Papers 1. A continuum of admixture in the Western Hemisphere revealedby the African Diaspora genome (Mathias et al.) Nature Communications Oct. 2016 Article number: 12522 (2016) doi:10.1038/ncomms12522. 2. Co-associationsbetweenIL-10polymorphisms,IL-10production,helminthinfectionandasthma/wheeze inan urban tropical populationinBrazil. FigueiredoCA,BarretoML, Alcantara-NevesNM,RodriguesLC,CooperPJ, Cruz AA, Pontes-de-CarvalhoLC,Lemaire DC,dosSantosCosta R, AmorimLD,Vergara C,RafaelsN,Gao L, Foster C, Campbell M,MathiasRA, BarnesKC: J AllergyClinImmunol.2013 Jun;131(6):1683-90. doi: 10.1016/j.jaci.2012.10.043. Epub 2012 Dec 28. Erratum in:J AllergyClinImmunol.2013 Oct;132(4):1015. 3. A genome-wideassociationstudyonAfrican-ancestrypopulationsforasthma. MathiasRA,Grant AV,RafaelsN, Hand T, Gao L, VergaraC,Tsai YJ, Yang M, Campbell M,FosterC,Gao P, TogiasA, Hansel NN,Diette G,Adkinson NF,Liu MC, Faruque M, DunstonGM, WatsonHR, BrackenMB, Hoh J, Maul P,Maul T, JedlickaAE,MurrayT, Hetmanski JB,AshworthR,OngacoCM, HetrickKN,DohenyKF,PughEW, Rotimi CN,FordJ, Eng C, Burchard EG, SleimanPM,HakonarsonH, FornoE, Raby BA,WeissST, Scott AF,KabeschM, LiangL, AbecasisG,MoffattMF, CooksonWO,Ruczinski I,BeatyTH, BarnesKC: J AllergyClinImmunol.2010 Feb;125(2):336-346.e4. doi: 10.1016/j.jaci.2009.08.031. Epub 2009 Nov11. 4. Africanancestryisa risk factorfor asthma andhightotal IgE levelsinAfricanadmixedpopulations. VergaraC, Murray T, RafaelsN,LewisR,Campbell M,FosterC,Gao L, Faruque M, OliveiraRR,CarvalhoE,AraujoMI, Cruz AA,WatsonH, Mercado D, Knight-MaddenJ,Ruczinski I,DunstonG, Ford J,CaraballoL, BeatyTH, Mathias RA, BarnesKC: GenetEpidemiol.2013 May;37(4):393-401. doi:10.1002/gepi.21702. Epub 2013 Apr2. 5. 2015 PosterPresentationentitled“Anapproachforattainingdocumentsconsistentwith45CFR Part 46 researchinvolvinghumanparticipantsandthe developmentof consortiumwaiverandumbrellaprotocol and Certificatesof Confidentialityforthe ConsortiumonAsthmaamongAfrican-ancestryPopulationsinthe Americas”(CAAPA JohnsHopkinsDepartmentof Medicine Research Retreat) 6. 2009 AmericanAcademyof Allergy,AsthmaandImmunologyOral presenteronthe topic“correlatingasthma severitytolungfunctiontestingratios(FEV1/FVC)” 7. 2009 PosterPresentationentitled“DoesFEV1/FVCCorrelatewithAsthmaSeverityScore inMonitoringAsthma Control?”JohnsHopkinsDepartmentof MedicineResearchRetreat:“New ModelsforScientificInvestigationat AcademicMedical Centers" Awards Certificate of Appreciation:Service Excellence (JohnsHopkins University),May2006 Committees and Memberships Member- AmericanAcademyof Allergy,Asthma&Immunology(AAAAI) Member- CAAPA Phenotype HarmonizationGrouphttps://hopkinspcc.org/caapa/
  • 5. Cassandra Foster, CCRP 6531 Pressed Gentian Columbia, MD 21045 443-878-6724, cassicroix@yahoo.com 5 | P a g e References Kathleen Barnes, PhD kathleen.barnes@ucdenver.edu 303-724-9734 Nicholas Rafaels, MS nicholas.rafaels@ucdenver.edu 303-724-9918 Candelaria Coggiano MD-PhD Candelaria.Coggiano@jhmi.edu 410-502-3717 Victor Ortega, MD vortega@wakehealth.edu 336-716-4649 Judith Carrithers, J.D. jcarrit1@jhmi.edu 443-287-0204