Dr.Pradeep Kumar

Experience

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  Gandhi Hospital, Secunderabad, Telangana

  Jan 2017 - Mar 2018

  Clinical Research Coordinator

  • Supported and coordinated the daily clinical trial activities and plays a critical role in the conduct of the study• Possessed a thorough knowledge of the informed consent process as well as a thorough understanding of the study protocol in order to be able to answer all questions pertaining to the study posed during the informed consent process.• Coordinated with the approval of new study agreements and contracts.• Coordinated and attended sponsor Site Selection visits, Routine monitoring visits, and study close out visits.• Completed case report forms. Extracted data from patient file (Source documents) in a timely manner. Responded to data clarification requests in a timely manner.• Coordinated with PIs and department to help ensure that clinical research and related activities are performed in accordance with protocol, SOP, GCP and applicable regulatory requirement.• Maintained subject screening, Randomization, Identification, protocol deviation and all other logs pertaining to the study.• Maintained excel sheets, tracking updates to database of all subjects enrolled on clinical trials.• Assisted the Principal Investigators in submission of accurate and timely closeout documents to applicable IRB/IEC and applicable regulatory requirement Show less

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  Clinwave research private limited

  Apr 2018 - Jul 2021

  Clinical Research Associate

  • Preparing, Planning and Organizing the Site Initiation, Monitoring and Close-out Visits.• Prepare and submit visit SQV, SIV, SMV, SCV reports in a timely manner.• Involving in recruiting the potential Principal Investigators, Preparation of Independent Ethics Committee / Independent Regulatory Board (IEC / IRB) submissions, notifications to Regulatory Authorities and other tasks as instructed by the Project Manager.• Oversees all aspects of Study site management to ensure high quality data resulting in low query levels and good quality assurance reports.• Execute trials as per ICH-GCP guidelines and SOP of the Organization.• Communicate effectively with site personnel and review the Trial procedures at sites to minimize the errors that profound during the trial. Show less

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  IQVIA India

  Jul 2021 - now

  Site Report Reviewer