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Global Site Manager

1 week ago

Kuala Lumpur, Kuala Lumpur, Malaysia Syneos Health, Inc. Full time
Job Summary

The Senior Clinical Research Associate I (SCRA I) plays a crucial role in ensuring the successful execution of Phase I-IV clinical research projects. This position requires strong clinical research expertise and excellent communication skills.

You will be responsible for monitoring and site management activities, conducting site qualification, initiation, interim monitoring, site management, and close-out visits to ensure regulatory compliance.

Main Responsibilities
  • Verify informed consent has been adequately performed and documented for each subject/patient as required/appropriate.
  • Assess site processes and conduct Source Document Review of relevant site source documents and medical records.
  • May perform investigational product inventory, reconciliation, and review storage and security.
  • Document activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents.
  • Understand project scope, budgets, and timelines for own and others' activities in the clinical team; manage site-level activities/communication to ensure project objectives are met.