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Study Site Coordinator

2 weeks ago

Perth, Western Australia beBeeClinicalResearch Full time $90,000 - $120,000
Clinical Research Associate

Job Summary:

A Clinical Research Associate is responsible for project management and study site management from site selection to initiation until monitoring and close-out of assigned clinical studies in accordance with standard operating procedures, international conference on harmonization good clinical practice standards, and other applicable regulations.

Key Responsibilities:

  • Site Management: Study site selection, initiation (SIV), and clinical monitoring. Ensure eligible sites are selected according to sponsor site selection criteria, including adequate resources and experience.
  • Training: Provide ongoing training to site staff regarding ICH-GCP, GCP, study protocol, and requirements. Conduct site initiation to ensure the site has a thorough understanding of the study protocol and requirements.
  • Documentation: Ensure timely collection of essential documents in compliance with the protocol and regulations at study start-up, during, and at study close-down. Maintain and update these documents in investigator files and trial master files.

Requirements:

  • Strong knowledge of SOPs, ICH-GCP, and GCP
  • Excellent communication and organizational skills
  • Ability to work independently and as part of a team

Skills Required:

  • Knowledge of SOPs, ICH-GCP, and GCP
  • Communication and organizational skills
  • Independent working and teamwork ability

Benefits:

The role provides opportunities for professional growth and development through training and networking.

Opportunities:

This role offers a dynamic work environment and collaboration with experienced professionals.