Casual Hourly Rate: $47.02 per hour + 11% superannuation

Employment Type: Casual 

Location: Flexible

About the Role: 

The Clinical Trials Monitor will be responsible for the monitoring of investigator-initiated mental health clinical trials.  The role will provide services for both pharmaceutical and non-pharmaceutical trials, conducted within the university and MAGNET partners. The role is crucial in ensuring that trials comply with regulatory requirements, adhere to best practices, and meet the highest standards of integrity and accuracy. The position is sessional, reflecting periods of variable activity, and may transition to a part-time role.

To Be Successful, you'll have:

Required:

• Undergraduate qualification in a scientific or healthcare discipline
• Experience with Clinical Trial Monitoring
• Experience with data integrity and management activities.
• Regulatory Savvy: Strong knowledge of ICH-GCP guidelines, ISO 14155, and The Therapeutic Goods Act and NHMRC guidelines.
• Tech-Savvy: Proficiency in Microsoft Office, and relevant technology.
• Communication Pro: Excellent written and verbal skills.
• Organized and Analytical: Strong organizational and problem-solving abilities with an exceptional eye for detail.
• Time and Financial Management: Effective in managing time and finances.
• Team Player: Ability to build and maintain strong relationships with co-workers, managers, and clients

Desirable:

• Educational Excellence: PhD in a scientific or healthcare discipline preferred.
• Postgraduate degree
• Experience:  Experience in the conduct and management of mental health clinical trials

Your key responsibilities will be to:

• Ensure compliance with study protocols, investigational product accountability, and applicable regulations.
• Engage in site visits to review documentation.
• Champion Quality and Integrity: Evaluate and enhance site practices, ensuring adherence to protocols and regulations. Undertake data quality activities to ensure data integrity (e.g., data monitoring and cleaning).
• Master Documentation: Ensure meticulous records are kept, with all site documentation well maintained.
• Collaborate and Innovate: Work closely with a passionate team to support project execution and drive success.
• Manage and provide advice and accountability for day-to-day operations of the project, as defined by the protocol, contract and in compliance with ICH/GCP and all other applicable laws, rules, and regulations
• Build and maintain strong relationships with investigational sites, investigators, and study coordinators.
• Monitor study progress, identify potential issues and assist in identifying appropriate corrective actions.
• Assist in the preparation and review of study-related documents and reports.

Additional requirements: 

• The role requires the incumbent to apply for and maintain a Working with Children
  Check.

Should you have any queries regarding the advertised role, please reach out to magnet@deakin.edu.au.

Please submit your updated resume and 1 page cover letter. Applications for this position close on 30/04/2025.