Clinical Research Associate

Primary Responsibilities:

1. Off-site Monitoring

• Undertake off-site visits during different phases of the study period.
  
• Conduct Initial Site Visits as per the study plan to train and guide site personnel.
  
• Inspect pre-requisites as per protocol and ensure the site is ready for the study.
  
• Perform routine monitoring visits at predetermined frequencies as per study guidelines.
  

2. Communication & Documentation

• Communicate with potential sites for Feasibility Assessment Questionnaires and obtain required details for review.
  
• Follow up regularly with off-site nodal personnel/in-charge and prepare visit reports (Pre-study Qualification Report, Site Initiation Visit Report, Site Monitoring Visit Report, Site Closeout Visit Report) as per defined frequency and submit for review.
  
• Procure required documents (e.g., calibration reports, agreements, etc.) from sites and vendors during study start-up and throughout the study.
  
• Provide various data formats (logs, forms, source data templates, recruitment trackers, feasibility questionnaires, etc.) to the off-site team and ensure proper data capture/recording.
  

3. Audits & Compliance

• Review study-related documents generated during the study to ensure compliance with relevant SOPs, protocols, and regulatory requirements.
  
• Train, guide, and mentor the off-site team on study protocols and regulatory aspects (GCP, Root Cause Analysis, updated regulatory requirements, etc.) periodically.
  
• Respond to and comply with queries raised by internal (QA/QC) and external (Sponsor/Regulatory) auditors.
  
• Perform any other tasks assigned by the reporting authority.