Kalyani Kalkar

Clinical Research Associate at Advarra
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Contact Information
us****@****om
(386) 825-5501
Location
Nagpur, Maharashtra, India, IN

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Credentials

  • Deveoping Learning Mindset
    LinkedIn
  • ICH GCP certificate
    Department of Pharmacology nagpur
  • Post Graduate Diploma in Clinical Research
    Canvas Clinical Research pvt. lit.

Experience

  • Advarra
    • United States
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Clinical Research Associate
      • Aug 2022 - Present

    • Clinical Research Consultant
      • Mar 2022 - Aug 2022

  • Q RED Clinical Research Services
    • Nagpur, Maharashtra, India
    • Clinical Research Coordinator
      • Nov 2021 - Mar 2022

      •Coordinating all the activities related to clinical trials. •Supporting and coordinating with PI, Informed Consent process, Drug Dispensing. •Reviews and comprehends the protocol. •Prepares other study materials as requested by the PI. These study materials include the informed consent document, case report forms (CRFs), enrollment logs, and drug/device accountability logs. •Scheduling patient visits and follow ups. Participated it SIV and monitoring visits. •To conduct clinical… Show more •Coordinating all the activities related to clinical trials. •Supporting and coordinating with PI, Informed Consent process, Drug Dispensing. •Reviews and comprehends the protocol. •Prepares other study materials as requested by the PI. These study materials include the informed consent document, case report forms (CRFs), enrollment logs, and drug/device accountability logs. •Scheduling patient visits and follow ups. Participated it SIV and monitoring visits. •To conduct clinical trials in adherance with Good Clinical Practices and compliance with protocol. •Reporting of SAE and SUSAR to Ethics committee and sponsors. •Data entry of the patients into clients database. •Completes study documentation and maintains study files in accordance with sponsor requirements and University policies. Show less •Coordinating all the activities related to clinical trials. •Supporting and coordinating with PI, Informed Consent process, Drug Dispensing. •Reviews and comprehends the protocol. •Prepares other study materials as requested by the PI. These study materials include the informed consent document, case report forms (CRFs), enrollment logs, and drug/device accountability logs. •Scheduling patient visits and follow ups. Participated it SIV and monitoring visits. •To conduct clinical… Show more •Coordinating all the activities related to clinical trials. •Supporting and coordinating with PI, Informed Consent process, Drug Dispensing. •Reviews and comprehends the protocol. •Prepares other study materials as requested by the PI. These study materials include the informed consent document, case report forms (CRFs), enrollment logs, and drug/device accountability logs. •Scheduling patient visits and follow ups. Participated it SIV and monitoring visits. •To conduct clinical trials in adherance with Good Clinical Practices and compliance with protocol. •Reporting of SAE and SUSAR to Ethics committee and sponsors. •Data entry of the patients into clients database. •Completes study documentation and maintains study files in accordance with sponsor requirements and University policies. Show less

  • Central Citrus Research Institute
    • Nagpur, Maharashtra, India
    • Young Professional II
      • Feb 2020 - Jun 2020

Education

  • Rashtrasant Tukadoji Maharaj Nagpur University, Nagpur
    Masters degree, Biochemistry
    2017 - 2019
  • Canvas clinical research pvt lit Nagpur
    PGDCR, Clinical research
    2021 - 2021
  • Dr. Ambedkar College,Nagpur
    Bachelor's degree, Biotechnology,Biochemistry,Chemistry
    2014 - 2017
  • Vidarbh Buniyadi Jr. College, Nagpur
    HSC
    2012 - 2014
  • Nagar Parishad Highschool Narkhed
    SSC, 87%
    2011 - 2012

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