Clinical Research Associate Professional

7 days ago


Adelaide, South Australia Novotech Full time
Job Description

The Clinical Research Associate is a pivotal role responsible for ensuring the rights and well-being of trial participants are protected. The primary contact between Investigational Sites, Novotech, and Sponsors, the CRA plays a crucial site relationship manager ensuring clinical trials are conducted in accordance with ICH GCP guidelines, local and global regulatory requirements, and Novotech SOPs.

Key Responsibilities
  • Build relationships with Principal Investigators, study coordinators, pharmacists, and all relevant site trial personnel to ensure efficient, expedited, and smooth management of clinical trials.
  • Foster internal and external customer relationships to ensure focus on efficient, timely, and productive project delivery as per study requirements and timelines.
  • Collaborate with In-house Clinical Research Associate (IHCRA) and Regulatory Start-up Associate (RSA), prepare site essential documents, and support ethics and regulatory submission and approval processes as needed.
  • Understand requirements of applicable local and international regulatory requirements as relevant to specific clinical trials, in collaboration with Regulatory Start-up (RSU) Team.
  • Ensure recruitment of participants as per site target, drive site recruitment and engagement initiatives, and prepare site-specific recruitment plan(s) and update as required.


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