Senior Clinical Research Associate

5 days ago


Nagpur, Maharashtra, India Parexel Full time

Unlocking Clinical Trial Success

The Early Clinical Development Senior Clinical Research Associate will be responsible for conducting monitoring activities for multiple client-sponsored studies, adhering to Good Clinical Practices (GCP), International Conference on Harmonization (ICH), and client Standard Operating Procedures (SOPs).

Key Responsibilities:

  • Perform site management activities to ensure compliance with the protocol, monitoring plan, GCP, ICH, and SOPs.
  • Monitor clinical trial quality and site management for client-sponsored studies.
  • Conduct site qualification, initiation, interim, and close-out visits.
  • Ensure sites meet performance expectations related to recruitment, enrollment, and retention.
  • Review site source documentation, case reports, and verify accurate data capture.
  • Ensure timely submission of study documentation and perform drug accountability, reconciliation, and destruction.
  • Identify and record protocol deviations.
  • Maintain ongoing communications with site personnel and analyze issues to make informed decisions.

Requirements:

  • Minimum 5 years of relevant industry experience.
  • Bachelor's Degree or equivalent.

Parexel is an Equal Opportunity Employer



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