Senior Freelance CRA/Consultant

We are seeking an experienced freelance Clinical Research Associate (CRA) to support a clinical trial across Australian sites. The CRA will be responsible for independent site monitoring, ensuring data quality, regulatory compliance (ICH-GCP, TGA), and supporting patient recruitment and retention. This role requires strong site engagement skills and the ability to manage multiple sites proactively.

Can work 2–3 Days/Week

• Conduct onsite and remote unblinded monitoring visits, with primary responsibility for pharmacy and investigational product oversight across study sites.
• Perform site initiation, routine monitoring, and close-out activities related to unblinded/pharmacy-specific study procedures, in accordance with the Clinical Monitoring Plan.
• Review investigational product accountability, receipt, storage, temperature monitoring, dispensing, returns, destruction, and reconciliation at study sites, as applicable.
• Verify that pharmacy documentation is complete, accurate, and maintained in accordance with the protocol, pharmacy manual, sponsor requirements, and applicable regulatory requirements.
• Ensure unblinded study activities are conducted in compliance with protocol requirements and that appropriate segregation is maintained between blinded and unblinded study personnel and documentation.
• Identify, document, track, and escalate pharmacy-related issues, investigational product discrepancies, protocol deviations, temperature excursions, and other quality concerns to the appropriate study team members.
• Review relevant source documentation and study records related to investigational product handling and unblinded site activities, as applicable.
• Prepare and submit monitoring visit reports, follow-up letters, and action items within required timelines.
• Support the maintenance of essential unblinded study documents and contribute to Trial Master File quality and inspection readiness.
• Build and maintain effective working relationships with site pharmacists, pharmacy staff, investigators, and study coordinators to support compliant study conduct.
• Provide training and guidance to site pharmacy staff on investigational product handling, accountability, storage requirements, and unblinded study procedures, as applicable.
• Communicate pharmacy site status, risks, investigational product issues, and key updates to the Clinical Operations team and other relevant stakeholders in a timely manner.
• Ensure all unblinded site activities are conducted in compliance with ICH-GCP, company SOPs, the study protocol, pharmacy manual, and applicable Australian regulatory and ethics requirements.
• Oversee and track investigational product management at study sites, including IP ordering, receipt, inventory, storage, temperature monitoring, dispensing, returns, and reconciliation, and work with site pharmacy staff and relevant vendors to ensure adequate supply is maintained throughout the study.

• A university degree in Life Sciences, Pharmacy, Nursing, or a related field is required.

• Full legal working rights in Australia are required.

• Minimum 5 years of independent onsite monitoring experience as a Clinical Research Associate within a Sponsor or CRO environment, including prior experience monitoring clinical trial sites in Australia.
• Previous experience as an unblinded CRA or in monitoring roles with primary responsibility for pharmacy and investigational product oversight is required.
• Strong knowledge and practical application of ICH-GCP, investigational product management requirements, and applicable Australian regulatory requirements, including TGA requirements.
• Demonstrated experience reviewing investigational product accountability, storage conditions, temperature logs, dispensing records, reconciliation, and pharmacy documentation.
• Demonstrated ability to maintain strict separation of blinded and unblinded activities and manage unblinded information appropriately.
• Strong attention to detail, with excellent analytical, problem-solving, organisational, and time management skills.
• Proven ability to work independently, manage multiple priorities, and deliver high-quality monitoring activities within required timelines.
• Strong interpersonal and communication skills, with the ability to build effective relationships with pharmacists, site staff, and cross-functional study teams.

• Proficient in Microsoft Office Suite; experience with EDC and CTMS systems is preferred.
• Proficient in Microsoft Office applications (Word, Excel, PowerPoint, Outlook).
• Experience with electronic data capture (EDC) systems and clinical trial management systems (CTMS).
• Strong written and verbal communication skills, with the ability to interact effectively with cross-functional teams and site personnel.
• High level of attention to detail, with strong organisational and documentation skills.
• Ability to work independently in a remote and field-based environment.
• Experience with investigational product management and pharmacy-related documentation is highly desirable.

• Valid driver’s licence and willingness to travel domestically to investigational sites across Australia.
• Ability to undertake regular onsite monitoring visits, with expected travel of approximately 40–60% depending on site location and study needs.

This job description outlines the key responsibilities and requirements of the role and is not intended to be an exhaustive list of all duties. Responsibilities may be adjusted in line with study needs and organizational priorities.