Senior Clinical Research Associate

3 weeks ago


Pune, Maharashtra, India Clini Launch Research Institute Full time

Clinical Research Associate - Senior Study Manager

At Clini Launch Research Institute, we are seeking an experienced Clinical Research Associate to join our team as a Senior Study Manager. In this role, you will be responsible for the preparation and execution of Phase I-IV clinical studies, with a focus on monitoring and site management activities.

Key Responsibilities:

  • Prepare, conduct, and report on site selection, initiation, routine monitoring, and close-out visits
  • Monitor patient enrollment to ensure recruitment targets and project timelines are met
  • Perform source data verification and follow up on data queries at the site level
  • Ensure accurate and timely reporting and follow up of Adverse Events (AE)/Serious Adverse Events (SAE) and protocol deviations
  • Act as the main line of communication between the Sponsor and the site
  • Be a point of contact/liaison for in-house support services and vendors
  • Ensure proper handling, accountability, and reconciliation of Investigational Product(s) and clinical study supplies
  • Review the status and contents of essential documents at the site level and reconcile study OSF/TMF at the site level


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