Clinical Monitoring Specialist

4 days ago

Toronto, Ontario, Canada Parexel Full time
Job Summary:

The Clinical Monitoring Specialist will be responsible for ensuring the integrity of clinical data, maintaining regulatory compliance, and ensuring that sites are in compliance with International Council for Harmonization and Good Clinical Practice (ICH GCP) and local requirements. 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. The Clinical Monitoring Specialist will collaborate with the Site Manager to ensure that the site is in compliance with the protocol and is inspection-ready, will coordinate with institutions and investigators at the local level, and will collaborate with the Study Operations Manager (SOM), Global Study Manager (GSM), and Site Care Partner (SCP).

Key Responsibilities:
  • Ensure regulatory, ICH-GCP, and protocol compliance by evaluating overall site performance and providing recommendations for site-specific actions.
  • Verify the process of obtaining informed consent and ensure that it has been adequately performed and documented for each subject.
  • 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, as per the Clinical Monitoring Plan (CMP) or SMP.
  • Review and verify site source documents and medical records, including the Case Report Form (CRF).
  • 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.
  • Perform Investigational Product (IP) inventory, reconciliation, and reviews storage and security.
  • Verify 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.
  • Ensure all activities are managed by site personnel who are appropriately delegated and trained.
  • Enter data into tracking systems to track observations, ongoing status, and assigned action items to resolution.
Collaboration:
  • Collaborate with the primary Site Manager who will act as the primary liaison with site personnel.
  • Prepare for and attend Investigator Meetings and sponsor face-to-face meetings.
  • Participate in global clinical monitoring and project staff meetings, and attend clinical training sessions as required.
Process, Standards, and Oversight:
  • Provide guidance at the site and project level towards audit readiness standards and support preparation for audit and required follow-up actions.
Requirements:
  • A minimum of 1 year of 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) or ability to demonstrate agility to work with new systems to support monitoring practice.
  • Proficiency in local language is required.
  • English proficiency is required.
  • Ability to manage required travel of up to 75% on a regular basis.

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