Principal Investigator and Study Manager

1 week ago

Sydney, New South Wales, Australia beBeeClinicalResearch Full time $90,000 - $123,000

Role Overview

We are seeking a skilled Clinical Research Associate II to contribute to the success of our clinical trials.

Key Responsibilities:

  • Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials in compliance with regulatory requirements
  • Ensuring protocol adherence, data integrity, and patient safety throughout the trial process
  • Collaborating with investigators and site staff to facilitate seamless study conduct
  • Performing data review and resolution of queries to maintain high-quality clinical data
  • Contributing to the development and review of study documentation, including protocols and clinical study reports

Requirements:

  • Bachelor's degree in a relevant field such as life sciences, nursing, or pharmacy
  • Advanced degree preferred
  • Experience as Clinical Research Associate with on-site monitoring activities
  • In-depth knowledge of ICH-GCP guidelines and clinical trial processes
  • Strong leadership and mentoring skills, with ability to manage and motivate CRAs and site staff effectively
  • Excellent communication, organizational, and problem-solving skills, with proactive approach to managing site performance

What We Offer:

  • A dynamic work environment
  • Opportunities for professional growth and development
  • Competitive compensation and benefits package

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