Clinical Research Associate

3 weeks ago


Pune, Maharashtra, India Clini Launch Research Institute Full time

As a member of the Clini Launch Research Institute team, you will play a crucial role in the preparation and execution of clinical trials. Your focus will be on monitoring and site management activities, ensuring timely completion of site selection, initiation, routine monitoring, and close-out visits. You will build strong relationships with clinical sites and investigators, assessing protocol and regulatory compliance in accordance with local and federal regulations, as well as ICH GCP and PSI SOPs. Your primary goal will be to ensure the rights, safety, and well-being of subjects, while maintaining high-quality data.

  • Prepare, conduct, and report on activities related to site selection, initiation, routine monitoring, and close-out visits.
  • Monitor patient enrollment to ensure recruitment targets and project timelines are met at the site and/or country level.
  • Perform source data verification and follow up on data queries at the site level, reviewing Risk-Based Monitoring information to ensure data quality and frequency of site visits.
  • Act as the main point of contact between the Sponsor and the site, ensuring accurate and timely reporting of Adverse Events (AE) / Serious Adverse Events (SAE) and protocol deviations.
  • Be a liaison for in-house support services and vendors, ensuring proper handling, accountability, and reconciliation of Investigational Products and clinical study supplies.
  • Review the status and contents of essential documents at the site level, reconciling study OSF/TMF at the site and/or country level.


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