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Clinical Monitor

2 months ago

Toronto, Ontario, Canada Parexel Full time
Job Summary

The Site Monitor will be responsible for ensuring data integrity, quality, and compliance with International Council for Harmonization and Good Clinical Practice (ICH GCP) and local requirements at the site level. Monitoring will be conducted in line with the Study Monitoring Plan (SMP) and will be performed virtually for the majority of activities to supplement on-site visit requirements.

Key Responsibilities
  • Ensure regulatory, ICH-GCP, and protocol compliance, using judgment and experience to evaluate overall site performance and provide recommendations for site-specific actions.
  • Verify the process of obtaining informed consent has been adequately performed and documented for each subject as required.
  • Demonstrate diligence in protecting subject confidentiality and assess factors that might affect subject safety and clinical data integrity at the investigator site.
  • Conduct monitoring activities using different methods, such as on-site and remote monitoring, where allowed by country regulations.
  • Manage reporting of protocol deviations and follow up on issues.
  • Apply query resolution techniques remotely and on-site, and provide guidance to site staff as necessary.
  • Verify Investigational Product (IP) inventory, reconciliation, and storage, and ensure IP has been dispensed and administered to subjects according to the protocol.
  • Document activities via follow-up letters, monitoring reports, communication logs, and other required project documents.
Requirements
  • A minimum of 1 year experience as a clinical monitor/clinical research associate with demonstrated experience of on-site monitoring.
  • Experience of utilizing systems like Siebel Clinical Trial Management System (CTMS), electronic Trial Master File (eTMF), electronic Investigator Site File (eISF) (Florence).
  • Proficiency in local language and English.
  • Ability to manage required travel of up to 75% on a regular basis.
What We Offer

Parexel is a leading global biopharmaceutical services company that provides a comprehensive range of solutions to help clients succeed in drug and medical device development and commercialization.