Job Description

Job Description:

General Description:

  • The CRA executes clinical trial protocols at clinical trial sites and monitors clinical trials by ICH guidelines and GCP, local regulations, and applicable SOPs. The CRA performs monitoring activities related to initiation, conduct (recruitment, quality data collection) and timely completion of Oncology and Pharma clinical trials within the assigned region(country).
  • Accountable for the study start-up timelines and delivery.
  • Essential Functions of the job:

  • Conducts monitoring (pre-study, initiation, routine monitoring, and closeout visit), if require
  • Conducts co-monitoring visits, if required
  • Assists with investigator/site identification
  • Assists site to prepare Institutional Review Board/Ethics Committee (IRB/EC) submissions
  • Facilitates clinical trial site contract and budget negotiation
  • Manages site queries and communications
  • Assists ...
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