Dhwani Shah
Clinical research site Manager/Lead Clinical research coordinator at HOPE Research Institute- Claim this Profile
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Bio
Experience
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HOPE Research Institute
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Research Services
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1 - 100 Employee
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Clinical research site Manager/Lead Clinical research coordinator
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Jul 2020 - Present
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Lead Clinical Research Coordinator
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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
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Phoenix Medical Research Institute
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United States
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Clinical Research Coordinator
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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
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Education
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Stevens Institute of Technology
Master's degree, Pharmaceutical Manufacturing -
New Jersey Institute of Technology
Bachelor's Degree, Chemistry and Biology