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Summary

highly interested in the development of new treatments, guiding and mentoring junior CRA's and assistance to site staff with difficulties in recruitment and science)" >Protocol deviations.

Personality

Self Assessment :
Analytical thinkingTrustSelf-confidenceSelf-disciplineProblem solvingInterest in knowledgeOptimismInnovative thinkingIndependenceFlexibilityEfficiencyCompetitivenessCritical thinkingCollaborationAttention to detailApproachabilityStrategic thinking

Knowledge

Self Assessment :
NegotiationCancerClinical DevelopmentClinical monitoringClinical operationsClinical researchClinical trial audits and inspectionsClinical trialsContract negotiationCommunication SkillsCTMSData cleaningCross-functional team leadershipDrug Safety and PharmacovigilanceDermatologyEDCEnglishFDAGCPGMPGermanGynecologic oncologyICH GCP guidelinesIMPDInformed Consent ProcessMedical oncology Microsoft OfficeMonitoring Study ProgressNegotiationNeurologyNeurosurgeryNeuroscienceoncologyPatient Follow UpPatient Screening and Recruitmentpeople managementPharmaceutical IndustryPharmacokineticsPhase IIPhase IVPhase IIIPrinciples and ethics of clinical researchPsychiatryQuality of Life (QoL) outcomesRandomization and blindingRandomization SystemsSchizophreniaScreen patientsSOPSerious Adverse Event (SAE)Supervising CRAsTeam LeadershipTime ManagementUrologyInformed Consent Documents

Skills and Expertise

Self Assessment :
Assure medical quality Guide students Interact with nurses Interact with physicians Interpret data Monitor a clinical studyAdminister supply requestAdverse event reportingAdministrative supportApprove monitoring reportsApprove queriesApprove patient informationArchive study documentsAssess site feasibilityAssess subject safetyAssist study siteAssist with proceduresAssist with routine testsAttend investigator meetingCoach clinical staff Create SOPsCollaborate with medical teamCollaborate with principal investigatorCollect patient forms and questionnairesCommunicate with sponsorConduct close-out visitsConduct monitor visitsConduct site initiationConfirm protocol complianceControl dataData verificationDiscuss treatments with investigatorDocument adverse eventsEnsure good clinical practice (GCP)Ensure data integrityFacilitate sponsor monitoring visitsGeneral office managementGuide staffInitiation visitInteract with nursesInteract with pharmacistsInteract with physiciansFollow-up of internal auditsIdentify investigatorsInformed consent processManage Clinical Trial Management System (CTMS) managing a small teamMonitor a clinical studyMonitoring subject complianceMonitoring enrolmentNegotiationOffice managementPresent data at congressProvide trainingReport non-compliance incidentsReport serious adverse events (SAE)Review monitoring reportsReview queriesScheduling trial visitsSchedule sponsor monitoring visitsSchedule trial visitsSerious Adverse Event (SAE) ReconciliationSite management

Training and Certification

  • Clinical Research Auditing certification program in 2017 Training
  • Languages

    BrightOwl Assessment:
    Self Assessment:
    Dutch
    Native
    French
    Full Proficiency
    English
    Full Proficiency
    German
    Elementary Proficiency

Work Preferences

  • Notice Period:
    3 weeks
  • Positions I am interested in:
    Clinical Research Manager
  • Locations I am interested in:
    Wauberg, België
  • Work From Home:
    No
  • Work Regime:
    Permanent position :    1.0% FTE
    BrightOwl employee :    1.0% FTE
  • International:
    Yes

Area / Region

Wauberg, België

Others

Driving License
  • Yes

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