Clinical Trials Pharmacist

About the role

We are looking for a Clinical Trials Pharmacist to join a leading clinical research organisation in a new Sydney facility. The role operates in a fast‑paced, highly regulated environment, managing investigational products (IP) and supporting the delivery of clinical trials while ensuring compliance with GMP, GCP and local regulatory standards.

Key responsibilities

• Receive, store, dispense and maintain accountability of investigational products.
• Perform sterile and non‑sterile compounding in a cleanroom environment.
• Ensure accurate dispensing of IP according to patient, dose and protocol requirements.
• Maintain inventory control, documentation and audit‑ready records.
• Monitor and manage temperature‑controlled storage systems.
• Support clinical trial dosing activities and protocol adherence.
• Collaborate with clinical teams, sponsors and research staff to facilitate study delivery.
• Provide medication advice on dosing, administration and interactions.
• Participate in cleanroom monitoring, maintenance and environmental controls.
• Assist with study setup, documentation and IP preparation.
• Train staff on IP handling, dispensing and accountability.
• Participate in audits, monitoring visits and sponsor interactions.

Required profile

• Bachelor of Pharmacy (or equivalent) with current AHPRA registration.
• Minimum 2 + years experience as a registered pharmacist.
• Experience in clinical trials pharmacy or handling investigational products.
• Background in sterile/aseptic technique, cleanroom environments, or compounding settings.
• Strong understanding of GMP, GCP and relevant regulatory frameworks (e.g., TGA).
• High level of accountability, reliability and adherence to SOPs.

Required skills

• Sterile compounding
• Non‑sterile compounding
• Cleanroom operations
• Aseptic technique
• Inventory management
• Temperature‑controlled storage handling
• GMP compliance
• GCP compliance
• Regulatory knowledge (TGA)
• Medication dispensing and documentation