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- Prepare, conduct and report on activities related to the completion of site selection, initiation, routine monitoring and close-out visits
- Monitor patient enrolment 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, on-going review of any Risk Based Monitoring related information influencing data quality and frequency of site visits 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 all 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 and/or country level
Sr. Clinical Research Associate - Pune, India - Clini Launch Research Institute
Description
As a Senior CRA, you will participate in the preparation and execution of Phase I-IV clinical BA/BE studies with a particular focus on monitoring and site management activities to ensure timelines and deliverables are met at assigned sites. You will build and maintain strong relationships with clinical sites and investigators and assess protocol and regulatory compliance in accordance with applicable local and federal regulatory requirements, ICH GCP and PSI SOPs. You will focus on subjects rights, safety and well-being and ensure a high quality of data.