Clinical Research Associate (CRA)

Job Overview

We are looking for a detail-focused and proactive Clinical Research Associate (CRA) to join our expanding clinical operations team. This position involves on-site and remote management of clinical trial sites within Australia, ensuring all activities adhere to the study protocol, SOPs, ICH-GCP guidelines, and local regulations including TGA standards.

Key Responsibilities

• Oversee all phases of site management including site selection, initiation, monitoring, and close-out visits conducted both onsite and remotely.
• Safeguard participant rights by ensuring proper informed consent and adherence to protocol guidelines.
• Conduct thorough source data verification (SDV) to validate clinical data accuracy and completeness reported in case report forms.
• Monitor investigational product handling including accountability, storage, and reconciliation at trial sites.
• Identify, document, and resolve site-related issues, protocol deviations, and adverse events promptly.
• Prepare timely monitoring visit reports and follow-up correspondence.
• Maintain trial master file documentation to ensure readiness for audits.
• Establish and nurture strong working relationships with investigators and site staff.
• Provide ongoing training related to protocol and study processes to site personnel.
• Report site progress, patient recruitment status, and data quality concerns to the clinical team.
• Ensure compliance of all site activities with ICH-GCP, company SOPs, and Australian regulatory requirements.

Required Qualifications and Experience

• A university degree in Life Sciences, Pharmacy, Nursing, or a related discipline is mandatory.
• Legal authorization to work in Australia is required.
• Two to four years of hands-on, independent CRA experience in monitoring clinical trials in a Sponsor or CRO setting within Australia.
• Thorough knowledge of ICH-GCP principles and Australian clinical trial regulations (TGA).
• Proven ability to manage site relationships and dynamics effectively.
• Exceptional detail orientation, analytical capabilities, and problem-solving skills.
• Highly organized with excellent time management to handle multiple concurrent tasks.
• Capable of independently managing tasks and collaborating within a team environment.
• Proficiency in Microsoft Office; familiarity with EDC and CTMS platforms is an advantage.

Additional Information

Applications must be submitted directly; third-party recruitment agencies will not be considered for this role.