Sr. Clinical Research Associate

435

Applications

Pune
Full-Time
Mid-Level: 4 to 6 years
5L - 8L (Per Year)
Posted on Feb 15 2023

About the Job

Skills

Clinical Research
Clinical
Research
CR
Pharmacovigilance
Regulatory Affairs
Clinical Trials

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. 

  • 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 



About the company

CLRI is an advance clinical research institute, Professional Training Centre that has been established to fix the current vacuum of value prepared assets/Professionals by being an urgent connection among Aspirant and Industry. Our excellent center is to elevate Pharmacy, Lifesciences, and Medicine including Paramedical alumni into Clinical Research Industry with our unrivaled long-time Industry or ...Show More

Industry

Education Administration ...

Company Size

51-200 Employees

Headquarter

Bengaluru

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