Rasika Joshi

Experience

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  Jehangir Clinical Development Centre (JCDC)

  Jan 2015 - Oct 2017

  In-depth knowledge of International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use - Good Clinical Practice (ICH GCP) guidelinesManaged and coordinated 15+ clinical trials from Phase I to Phase IV in compliance with study protocol and regulatory requirementsCollaborated with principal investigators and site staff to ensure protocol compliance and data qualityConducted regular monitoring visits and implemented corrective actions to address any deviations from protocols, query resolution from site monitoring visits, dispensed and stored investigational productsIdentified and interviewed 500 + potential eligible participants using inclusion and exclusion criteria defined by the studyParticipated in taking informed consent, explaining study subject matter, risk and benefits of the trialConducted follow up patient visits, ensure timely and accurate transcription of information on source documents and eCRFsMaintained and updated trial master fileHandling specimens and shipping of those to the lab for testingPrepared and submitted regulatory documents such as protocol amendments, site amendments, and annual reports, monitoring reports QA team, ethics committee, CRO and sponsorPrepared adverse event reports and submitted to the ethics committee,CRO and sponsorResolved queries from site monitoring visits, dispensed and stored investigational products Show less Worked closely with developers and project managers to understand the study requirements.Participated in requirement gathering and documentation in Confluence pages.Created user stories in JIRA for the developers. Conducted three amigos sessions to go over the requirement.Worked with QE lead to come up with the manual test cases according to the requirements.Performed manual eCRF testing to identify defects, inconsistency, usability issues.Defect reporting in JIRA. Show less Performed site monitoring, interim monitoring, prepared site monitoring visit report. Conducted site close out and corrective action visitDeveloped electronic CRFEvaluated protocol and regulatory compliance, including source document verification, informed consent process, data integrity, drug accountability, trial master file, investigator and regulatory filesCommunicated regularly with PI and site coordinator to check study complianceGuided site coordinator to report any adverse events Show less

  • Clinical Research Coordinator

    Jul 2014 - Oct 2017

  • Healthcare Business Analyst

    Jan 2016 - Jan 2017

  • Clinical Research Associate

    Jan 2015 - Jan 2016
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  Kent State University

  Jan 2020 - Mar 2022

  • Administrative Assistant

    Jan 2021 - Mar 2022

  • Doctoral Student

    Aug 2019 - Mar 2022

  • Teaching Assistant

    Jan 2020 - Dec 2020