Clinical Research Associate

4 days ago


Vancouver, British Columbia, Canada 44.01 Premier Research S.R.L. Remote Work Freelance Full time

About the Role:

We are seeking a highly skilled Senior Clinical Research Associate to join our Global Clinical Monitoring and Site Management team. As a Senior Clinical Research Associate, you will play a critical role in helping biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics.

Key Responsibilities:

  • Deliver quality, timely monitoring reports for sponsor approval per the Clinical Monitoring Plan timelines.
  • Maintain submission of expenses according to travel and expense requirements within company guidelines.
  • Monitor (remote, onsite or other approved mode of monitoring) with a focus on data integrity and patient safety in accordance with specific country regulations.
  • Plan day-to-day activities for monitoring of a clinical study and set priorities per site.
  • Prepare for and conduct on-site qualification, study initiation, interim monitoring and close-out monitoring visits at investigator sites as required by clinical monitoring plan.
  • Maintain Trial Master File (TMF)/electronic Trial Master File (eTMF) as defined by the organization's processes per filing guidelines.

Requirements:

  • Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution; a licensed health-care professional (i.e., registered nurse); or equivalent work experience required.
  • Previous clinical research experience required and proven independent monitoring to include all visit types.
  • At least 3+ years' experience in clinical trials monitoring.


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