Dr. VIPUL BHAVSAR

Experience

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  Wockhardt Hospitals Ltd

  Aug 2014 - May 2015

  Clinical Assistant (ICU)
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  AARPL

  Jul 2015 - May 2017

  Clinical Research Associate

  1) Meet with Clinical Investigators and staff prior to study initiation to ensure all aspects of the study are understood by the investigator and staff. If required train the study site team. To confirm the appropriateness of the site for the study in all aspects and ensure that all documentation required initiating the study is complete. 2) To assist study team member in assessing the site feasibilities, performing various administrative duties. 3) Perform literature search on regulatory requirement. Designing of trial related documents (e.g. protocol, ICD-PIS, Case Report Form, PDDC).4) To assist with preparation of required regulatory submissions.5) Compile and maintain regulatory documentation databases or systems.6) To assist clinical sites with IRB/IEC submissions and ensure collections of required essential documents for study start up and throughout conduct of study.7) Registration of trials in Clinical Trial Registry of India.8) Monitor study progress to assure compliance with protocol requirements and Good Clinical Practice by conducting site visits. 9) Monitor and track patient enrollment and study progress. 10) Perform site monitoring visits to include review of source document, case report form, ICD, Patient Diary, other documents as applicable. 11) Verifying the all documents provided by investigator.12) Checking the accuracy and completeness of CRF entries, source documents and other trial related records against each other.13) Prepare for or participate in quality assurance audits conducted by study sponsors.14) To ensure data required by the protocol are reported accurately on the CRFs and are consistent with the source documents.15) Prepare a TMF (Trial Master File) for clinical study.16) Determine whether all adverse events are appropriately reported within the time periods required by Good Clinical Practices (GCP), the Protocol, the Ethics Committee (IRB/IEC), the sponsor and the applicable regulatory requirements. Show less

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  Tata Consultancy Services

  Jun 2017 - Feb 2020

  Drug Safety Associate
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  Cognizant

  Mar 2020 - now

  Drug Safety Associate