Dhwani Shah

Clinical research site Manager/Lead Clinical research coordinator at HOPE Research Institute
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Languages
  • English -
  • Hindi -
  • Gujarati -

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Experience

    • Research Services
    • 1 - 100 Employee
    • Clinical research site Manager/Lead Clinical research coordinator
      • Jul 2020 - Present

    • Lead Clinical Research Coordinator
      • Aug 2016 - Jul 2020

      Coordinated clinical Phase II, III and IV trials in Pain management, GI and Neurology  Coordinated clinical Phase II, III and IV trials in Endocrine and women Health

    • Clinical Research Coordinator
      • Apr 2014 - Aug 2016

       Coordinated clinical Phase II, III and IV trials in Pulmonary Disease Coordinated clinical Phase II, III and IV trials in Endocrine and women Health  Performed Regulatory filings Ensured Research Department compliance with HIPPA, ICH/GCP and FDA guidelines.  Collaborated with research Monitors in providing accurate, concise clinical data for individual studies.  Implemented and follow IRB approved protocols.  Generated study source documents when appropriate.  Responded to queries in a timely manner and ensured successful site operations with maintaining essential and clean documents.  Dispensed study medications in compliance with individual study protocol.  Determined eligibility and recruited subjects based on inclusion and exclusion criteria Maintained and monitored proper storage of study medication/supplies.  Worked with PI to continue quality monitoring of care and services for patients.  Maintained adequate patient care; performed vitals, EKG's, collections of specimens and phlebotomy, performed spirometry test, processing and shipping of labs etc.  Ensured the completion of CRF's/EDC's. Attended Investigator meetings, Site initiate visit; pre-site visit and Site monitoring visit  Performed Study start up process

Education

  • Stevens Institute of Technology
    Master's degree, Pharmaceutical Manufacturing
    2010 - 2012
  • New Jersey Institute of Technology
    Bachelor's Degree, Chemistry and Biology
    2007 - 2009

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