Senior Clinical Research Associate

1 week ago


Nagpur, Maharashtra, India Parexel Full time

Parexel Career Opportunities

The Early Clinical Development Senior Clinical Research Associate will have relevant Phase I experience, responsible for conducting monitoring activities for one or more client sponsored studies.

Key Responsibilities:

  • Perform site management activities to ensure compliance to the protocol, monitoring plan, Good Clinical Practices (GCP), International Conference on Harmonization (ICH), Code of Federal Regulations (CFR), and client Standard Operating Procedures (SOPs).
  • Responsible for monitoring clinical trial quality and site management for client sponsored studies that are not fully outsourced to a contract research organization (CRO).
  • Conducts site qualification, initiation, interim, and close-out visits.
  • Ensures sites meet performance expectations related to recruitment, enrollment, and retention.
  • Reviews site source documentation, case reports, and verifies accurate data capture.
  • Ensures site regulatory files are current, and verifies the timely submission of study documentation (including safety reporting).
  • Performs drug accountability, reconciliation, and destruction. Verifies storage and shipment requirements are according to protocol.
  • Identifies and records protocol deviations.
  • Maintains ongoing communications with site personnel and assists with problem solving during all stages of study start up, conduct, and close out.


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