Clinical Research Associate II

7 days ago

Kirkland, Quebec, Canada IQVIA Full time
Job Title: Clinical Research Associate II - Oncology Monitoring

Job Summary:

IQVIA is seeking a highly skilled Clinical Research Associate II to join our team in Eastern Canada. As a Clinical Research Associate II, you will be responsible for monitoring and managing clinical trials in oncology, ensuring compliance with Good Clinical Practices and regulatory requirements.

Key Responsibilities:

  • Conduct site evaluation visits to assess the capability of investigators to manage and conduct clinical trials.
  • Collaborate with the ISSC department to coordinate activities with sites in preparation for study initiation.
  • Perform study initiation activities, reviewing protocol, regulatory issues, and study procedures with site personnel.
  • Monitor clinical trials, ensuring adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures.
  • Prepare monitoring reports and letters, using approved IQVIA templates and reports.
  • Document accountability, stability, and storage conditions of clinical trial materials.
  • Review the quality and integrity of clinical data through in-house review of electronic CRF data and on-site source verification.
  • Perform SAE review and reconciliation.
  • May review draft protocols, eCRFs, monitoring reports, and follow-up letters, study manuals, and other related documents.
  • May serve as primary contact between IQVIA and investigator, coordinating all correspondence and ensuring timely transmission of clinical data.
  • Perform study close-out visits, including final investigational product reconciliation and disposition, site study file reconciliation, data query resolution, and resolution of outstanding action items.

Requirements:

  • BS/BA/BSc (or equivalent) in one of the life sciences or health care background (RPh, RN, etc.) and a minimum of two (2) years of monitoring/site management experience.
  • Must possess 2+ years of oncology and/or medical device experience.
  • Experience in monitoring and/or coordinating clinical trials required.
  • Must be able to travel domestically approximately 65%-85%.
  • Valid driver's license.
  • Computer skills including proficiency in use of Microsoft Word, Excel, and PowerPoint.

About IQVIA:

IQVIA is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world.

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