Clinical Project Associate

Biotechnology

• Drug Development
• Clinical Operations The Company

Our client is an ASX-listed drug development company working to advance new treatments for cancer and fibrotic diseases. With multiple assets in their pipelines, their team is currently working across several studies at stages of progression ranging from preclinical, through to phase 2 trials.

The Opportunity

• Assist Clinical Research staff and the broader project team in a variety of clinical trial-related activities and processes, including patient recruitment, data collection, and monitoring trial progress.
• Prepare, manage, and archive clinical documentation and reports, ensuring compliance with regulatory requirements and company standards.
• Assist the project team in managing project budgets, invoices, and site payments, including tracking expenses and ensuring timely payments.
• Manage and maintain project systems and plans, including updating project timelines, tracking milestones, and ensuring all team members are informed of project status.
• Support study startup activities, including HREC and regulatory submissions, by preparing necessary documentation, coordinating with regulatory bodies, and ensuring timely approvals.
• Track incoming and outgoing clinical and regulatory documents and updates, maintaining accurate records and ensuring timely distribution to relevant stakeholders.
• Assist with the ordering, shipping, and tracking of site supplies and materials, including Investigational Products, ensuring timely delivery and proper inventory management. The Requirements
• Bachelor's degree or higher in a life sciences discipline, or equivalent.
• At least two years of clinical research experience gained in a Clinical Research Organisation, healthcare, biotech, pharmaceutical, or university setting.
• Good understanding of ICH GCP and other relevant guidelines.
• Demonstrated ability to thrive in a collaborative, cross-functional environment, solve problems effectively and seek support as required, and prioritise multiple tasks.
• Excellent verbal and written communication, and interpersonal skills
• Experience in oncology is preferred, however, we encourage you to apply if all other requirements are met. The Offer

To apply, please visit www.mexec.com and click Apply Now to submit your current CV and cover letter.