Priya Maistry Email & Phone Number

Sydney, Nsw, Au

Sydney, New South Wales, Australia

Sydney, New South Wales, Australia

Manage, prepare, initiate, and monitor clinical studies in compliance with international guidelines and local regulationsOrganize ethics committee and relevant regulatory submissions for clinical trialsConduct clinical trial initiation meetings at hospitals and facilitiesMonitor hospitals and patients compliance in clinical trialsEnsure accurate data is documented and collected for clinical trialVerify investigators and staff undertake timely and accurate reporting of Serious Adverse EventsEnsure all safety reporting is adequateNotify ethical committees of safety or deviations in clinical trialsEnsure electronic Trial Master File (e-TMF) is always updated as required to be audit inspection ready

Sydney, New South Wales, Australia

Complied with SOPs, study Protocol and Monitoring Plans, local and international regulationsEstablished effective recruitment plans for sites in start-up/recruitment phaseConducted site initiation meetingsPerformed study close-out visitsImplemented and conducted Risk Based Monitoring for identified studiesManaged local study files, including in-house files and reviewed site files for complianceDetected, documented, and reported protocol deviations/issuesEnsured accountability of clinical study supplies: non-investigational medicinal product and investigational medicinal productProvided timely written documentation of all site visits/contacts in appropriate reportsVerified CRFs/DRFs are completed/clarified within required study timelines, and data monitored as specified in the Monitoring Plan

Sydney, New South Wales, Australia

Ordered, tracked, and processed non-investigational medicinal products and investigational medicinal productsAssisted in administrative requirements for ethics committee regulatory submissionsPrepared and organized project-specific investigator meetingsSet up, prepared, and managed documentation, material, project files for site initiation, monitoring, closeout activities, and archivingUndertook the administrative processing of safety reports, as requiredParticipated in the development of project-specific documents and project toolsUndertook filing duties

Sydney, New South Wales, Australia

Ensured all clinical trials are managed in accordance with ICH-GCP guidelinesManaged IP dispensation, return, and destructionManaged laboratory equipment calibration and NATA accreditationEnsured trials complying with SOPs and ProtocolsPrepared and tracked budgetsPrepared contracts for stakeholdersPrepared and wrote Clinical Trial ProtocolsPrepared non-disclosures for stakeholdersEnsured EMRs were updatedUpdated sponsors of trial progress

Sydney, New South Wales, Australia

Johannesburg Metropolitan Area

Master'S Degree, Public Health & Health Management

Bachelor Of Science Degree, Microbiology And Biochemistry