Quality and Compliance Management Duties

Compliance Management Duties

1. Quality&ComplianceDuties
Location: Position:ClinicalComplianceManager#ofYears:
QualityAssurance&ComplianceDuties:
●Developed,coordinated,andmanagedqualitymanagementandregulatorycompliancefunctions
●PointPersonandSubjectMatterExpertregardingStudy&HIPAArelatedmattersforthePractice
●Mainfocus:elementsthataffectpatientsafety,ethicalconsiderations,anddataintegrity,guidedbydataanalysisand
riskindicator
Q&CTraining ●CreatedTrainingPrograms/MaterialsbasedonSOPs,internationalGoodClinicalPractices,FDA
GoodDocumentationPractices,applicablefederalregulations
●Submittingregulatory/essentialdocstoRegulatoryReviewBroad
●PerformingInformedConsentProcess
●PerformedMockFDASiteInspections
●Collecting&ReportingDeviationsandAdverseandSeriousAdverseEvents
●HIPAAPrivacy&SecurityregulationsregardingPHI/Confidential(annualandquarterlyreview
assessmenttests)
●TrainedDoctors,Fellows,RN,MA,andClinicalResearchCoordinators&Assistants
Collaboration&
Communicationwith
Internal&ExternalTeams
●CreatedExcelAnalysisTrackingLogs,WordDataAnalysis&QualityReviewStatus
Reportsforreviewwithleadership
●GavePowerPointpresentationswithinternalteams,management,studysponsors,and
externalstudysitesregardingstudyprojectstatusorquality&compliancestatsand
analysisalongwithimprovementrecommendations.

2. ●Conductedquality&compliancereviewswithexternalsitesconductingstudiesforprojects
wewereheadingandmanaging
Quality&Compliance
Reviews
●Performedweekly&monthlyreviewsandverificationofsourcedatadocumentscomparedto
MedicalRecordsandwithdataenteredinthesponsor’sdatacapturesystemstoensure
completenessandaccuracy
●Planned&performedroutineauditsofmultiplestudyprojectsbasedonarisk-basedapproachthat
targetedthehighestriskareaandensuredstudieswerebeingconductedviaGCP,GDP,SOPs,
StudyProtocolParameters&Regulations
●DocumentsReviewedduringAudits:
○SOPs
○ReviewAllEssentialRegulatoryFiles(Protocol,Manuals,Regulatory
Submissions/Approvals)
○InformedConsents
○StudyDataCollectionsDocuments(usedduringstudyvisits)
○Contract/StudyAgreements&Budgets
○SubjectEnrollmentLogs
○DeviationLogs
○AdverseEventLogs
○StudyDrugDispensingTrackingLog
○StaffQualifications,Credentials,andTrainingRecords
○StudySponsorMonitoringReports
●ObservedteamsperformingtheworktoconfirmifProcessesandProcedureswerebeingdone
correctlyandefficiently
●ImplementedCAPAsforAreasofImprovementifanycriticalorsystematicissueswere
discovered;
○CorrectiveActions(training,retraining,orrevisedSOPsorimplementationofnew
guidelines)
○PreventativeActions(createorrevisechecklist,workflows&workinstructions,install
2-personverificationsystem,orPIsign-offrequirement)

3. DataCollecting&AnalysisForStudyProjectsComplianceAssessments
●UsedExcelDataanalysisfeatureincludingpivottablebreakdownstoTrackKeyPerformance
Indicators,Trends,andComplianceIssues
●Examples:studyenrollment#s,completionrates,timelines&otherdeliverablesforeachstudy
phase,#ofDeviations,AdverseEvents,etc.
●ReceivedmonitoringreportsforsponsorindicatingNCissues,itemsthatweremissing,or
correctiveactionsneeded
●AlsousedthisinfotoCreateStudyReportsandQualityAssessmentReports
ForHIPAAComplianceAssessments
●Analyzetrainingresults/scoresbytestingemployeestoassessknowledge&understandingvia
annual&monthlytestingsessions
●Analyzenon-complianceeventsandincidentreportingpatternscollectedviatrackinglogsand
NetworkSecurityComplianceinformationgeneratedbytheComputerConsultingTeamwewere
contractedwith
●Fromtheimplementationofourtraininginitiative,Informationwasgatheredbeforetrainingand6
monthsafterwardwitha20%decreaseincomplianceissuesand40%bytheendoftheyear
QualityAssurance&
ComplianceTools
MaintainedAQuality&ComplianceSystemwithinMicrosoftApplicationProgramsthatconsistedofboth
SOPs&DocumentFoldersfor
●IncidentManagement
●RiskManagement
●DocumentManagement
●VersionControl
●TrainingManagement
●Non-conformance/incidentinvestigations
●CorrectiveandPreventiveActions(CAPA)
●Auditing/Monitoring

4. ●AccessControls/Permissions
●Archiving&Retention
RegulationsthatGoverned
ClinicalResearch
CFRTitle21,Parts,11,50,54,56,210,211,312,812,&820
Location:Medable(ResearchDataCollectionPlatform
SoftwareCompany)
Position:QualityAssuranceManager#ofyears:6mos
Gapanalysisofprocesses
andprocedures
BiggestComplaintfromInternalTeams
●ReviewedcurrentprocessesandproceduresforReportingQualityEvents
●GatherFeedbackfromemployeesonwhatwasworkingandwasworking
ProcessChange Informationcollectedfromthegapanalysisreportnotedsomekeyregulatoryrequirementsweremissing,
andfromemployeefeedback,theeventsubmissionprocesswasclunkyandtime-consuming
BasedonafewLeanSixSigmapractices,likeend-resultcustomersatisfaction,focusingonkey
problemareas,removingbottlenecksandunnecessarysteps,andensuringconstantcommunicationwith
theteamonthechangeprogress,wewereabletocreateamorestreamlinedworkflowprocess
Training&change
Implementation
●HeldmeetingswiththeTeamLeadsinformingthemofthechangesandhowthenewprocess
wouldworkandimprovetheeventreportingworkflowbasedontheirfeedbackandinput
●HeldTrainingsessionswitheachteamonhowtoimplementthenewprocess
●HelpcreatetheLMSSOPTrainingMaterialthatwaspushedouttotheteam
●SetupaFeedbackTeamchanneltoaddressanyquestionsregardingthisprocess
ThechangedProcess ●FormacommitteethatwoulddeterminehowtocategorizeaneventbasedonsubmittedIntake
Formsvshavingtheteamsmakethesechoices
●StreamlinefromrequiringfullRCAreview&CAPAsforallreportedeventstoonlyrequiring
RAC/CAPAsforcriticalandsystemicissuesorfromClientorRegulatoryAuditfindings
●Forminororone-offevents,Investigationswereperformed,immediatecorrectiveactionwastaken,
ifapplicable,andthedirectcausewasdeterminedvsRAC,justificationforwhyCAPAwasnot
needed,closedoutandtrackedfortrendsorrecurrences

5. ExamplesofActivitiesthat
weremonitored
Activitiesthatweremonitored
●#ofsites
●#ofPre-studyVisits&studypresentationscompletion
●RegulatoryDocumentCompletionTimeframe
●ReviewBoardSubmissionframe
●#ofsubjectenrolled
●#ofdropoutsorLTFUs
●#ofdeviation
●#ofAEsandSAES
●Timeforstudyinitiationtocloseout