Clinical Research Coordinator Montreal, QC, Canada
May 2016 --- September 2016
§ Working knowledge of International Conference on Harmonisation (ICH), Standard Operation Procedures (SOP), and Good Clinical Practice (GCP) guidelines
§ Participated in study closure visit.
§ Followed monitoring guidelines for each trial
§ Prepared source documents and equipment prior to patient visits.
§ Screened patients for inclusion and exclusion criteria.
§ Scheduled and coordinated patient visits.
§ Conducted standardized cognitive tests.
§ Was responsible for data entry on eCRFs, data matching and data editing.
§ Reviewed patient charts for study recruitment.
§ Worked on phase II-IV clinical studies.
§ Certified in Novartis’ Good Clinical Practice and Serious Adverse Effects Reporting.
§ Performed a wide range of clerical work related to clinical studies.
AdaptabilityAnalytical thinkingCollaborationCoordinationCritical thinkingInnovative thinkingProblem solving
Adverse Events (AE)Clinical Data ManagementClinical researchClinical trialsData AnalysisData entryData ManagementeCRFEnglishGood Clinical Practice (GCP)HealthcareInformed Consent DocumentsInformed Consent ProcessMicrosoft OfficeMicrosoft PowerpointMicrosoft WordWriting Study Procedures and SOPsTrainingTeam ManagementTeamworkTeachingTeam BuildingStudy protocolsStudy proposalsStudy outcomes and outcome measuresStatisticsStatistical Data AnalysisSerious Adverse Event (SAE)ResearchRecruitingQuality of Life (QoL) outcomesQualitative ResearchPublic SpeakingPhase IIPhase IIIObstetrics and gynecology
Skills and Expertise
Analyze data Interact with nurses Control dataAdverse event reportingClinical data collectionCollect dataConduct research at universitiesCreate clinical documentsWritten presentationWrite statistical reportsWork collaboratively with the other members of the clinical research team Verify dataValidate dataTeachingSerious Adverse Event (SAE) ReconciliationReview queriesReview informed consent processRead medical literatureR&DPrepare regulatory documentsMonitor dataLiaise with research team
Master in Education; Learning and Evaluation from University of Ottawa in 2015
Training and Certification
Good Clinical Practice in 2016 Certification
Serious Adverse Effects Reporting in 2016 Certification