Kiran Rajeev

Experience

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  WIKSATE SOLUTIONS PRIVATE LIMITED

  Jan 2017 - Apr 2017

  College Ambassdor
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  HMR Environmental Consultants

  Jan 2019 - Jan 2019

  Internship
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  TrialGuna Pvt. Ltd.

  Apr 2020 - Dec 2023

  1.Involved in the site management and monitoring of Phase 2, Phase 3 clinical trials.2.Contributed to clinical trials in Respiratory, Dermatology, Pediatrics, Gastrointestinal and Oncology indications, ensuring compliance with study protocols and regulatory requirements.3.Performed review of study specific documents. 4.Led the execution of two medical device trials,ensuring successful progression from initiation to closeout.5.Management of Clinical trials from site selection to site closeout.6.Performed site feasibility visit, SIV , interim monitoring visits and site closeout.7.Led study specific training of site team, Principal Investigator and in house team.8.Participated in budget negotiation with client and Vendors.9.Performed IP labelling and handling process.10.Contributed in management and onboard training of junior team members.11.Strategically assigned clinical studies and projects to junior team members, assessing their strengths and development areas to align with project needs. Show less 1.Led and managed a team overseeing the clinical trial process for the COVID-19 vaccine study.2.Successfully participated in a sponsor audit for a clinical trial. 3.Involved in Investigational Product (IP) randomisation and accountability.4.Assisted Principal Investigator in recruitment of 1000+ subjects at site.5.Assisted in audio video consenting process.6.Perfomed Serious Adverse Event (SAE) reporting.7. Managed trial associated vendors and clients.8.Assisting the Principal Investigator and hospital team in follow up visits.9.Managed logistics of sample transportation from site to labs.10.Assisted in the Investigational Product destruction process. Show less 1.Worked on multiple clinical trials related to COVID-19 indications.2.Successfully oversaw and managed clinical trials concurrently, ensuring efficient execution and compliance.3.Assisted Principal Investigator in Informed consent process.4.Assisted in transfer and receipt of temperature controlled samples/Investigational Product.5.Maintained Trial Master Files and subject files at site.6.Assisted Principal Investigator in subject follow ups.7.Maintained temperature logs for Investigational products8. Performed data entry on edc platforms such as Clinion, Oracle Clinical, OpenClinica. Show less

  • Clinical Research Associate

    Jun 2021 - Dec 2023

  • Lead Clinical Research Coordinator

    Jan 2021 - Jun 2021

  • Clinical Research Coordinator

    Oct 2020 - Jan 2021

  • Clinical Research Coordinator

    Apr 2020 - Sept 2020