Rashmi Warrier

Experience

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  IQVIA

  Apr 2011 - Sept 2012

  Clinical Trial Assistant

  Assist Clinical Team Lead (CTL) and Clinical Research Associates (CRAs) with accurately updating and maintainingclinical systems that track site compliance and performance within project timelines.• Assist the clinical team in the preparation, handling, distribution, filing, and archiving of clinical documentation andreports according to the scope of work and standard operating procedures. Assist with periodic review of study files foraccuracy and completeness.• Assist CTLs with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information.• Act as a central contact for the clinical team for designated project communications, correspondence and associateddocumentation.• May perform assigned administrative tasks to support team members with clinical trial execution. Show less

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  IQVIA India

  Oct 2012 - May 2016

  SENIOR CLINICAL TRIAL ASSISTANT

  Assist Clinical Team Lead (CTL) and Clinical Research Associates (CRAs) with accurately updating and maintainingclinical systems that track site compliance and performance within project timelines.• Collaborate with CTL on the preparation, handling, distribution, filing, and archiving of clinical documentation and reportsaccording to the scope of work and standard operating procedures. Assist with periodic review of study files for accuracyand completeness.• Collaborate with CTL on the preparation, handling and distribution of Clinical Trial Supplies and maintenance of trackinginformation.• Act as a central contact for the clinical team for designated project communications, correspondence and associateddocumentation.• Assist in training and orienting new staff. May act as a mentor for less experienced CTAs.• Accompany CRAs on site visits to assist with clinical monitoring duties upon completion of required training and withrequired approval.• Perform assigned administrative tasks to support team members with clinical trial execution. Show less

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  IQVIA

  Jun 2016 - Mar 2019

  REGULATORY & START UP SPECIALIST

  • Responsible for the start-up, initiation, implementation and the management of clinical trials for the assigned sites.Provides site management and monitoring support for sponsored clinical studies.Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.Ensure that the Site Regulatory Documents are complete and current through trial.Ensure copies/originals (as required) of site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.Develops and demonstrate an understanding of and apply therapeutic area knowledge to assignments and project-related issues.Appropriately resolves issues related to trial monitoring and management with guidance from Project Manager.Prepares for and attends Investigator Meetings responsible for the evaluation of clinical data to ensure investigator and site compliance with the study drug protocol, overall clinical objectives, FDA regulations, ICH/GCP Guidelines.Accountable for site financial management according to executed clinical trial agreement.Manage time effectively in order to fulfill requirement to meet all timelines, in both therapeutic work and submission of administrative documents. Show less