Clinical Trials Assistant

Are you passionate about clinical research and thrive in a dynamic, collaborative environment? Join SAPRO as a Clinical Trials Assistant (CTA) and play a vital role in advancing innovative therapies and supporting ground-breaking clinical trials.

About the Role

As a CTA at SAPRO, you'll be an essential member of our clinical operations team. You'll support our Clinical Research Associates (CRAs), Project Managers, and Directors, and work alongside our research sites closely to execute fast paced First in Human - Phase III trials. You'll also liaise directly with sponsors to ensure smooth and efficient trial execution.

Key Responsibilities

• Ensure complete and accurate study administration in line with ICH-GCP guidelines, ISO 14155 and SOPs.
• Prepare and maintain clinical trial documentation in our systems including CTMS, e-TMF, e-ISFs.
• Willingness to learn and coordinate vendor management systems and coordination of pertinent trial logistics in support of your team.
• Assist with Ethics Committee and regulatory submissions and site supplies.
• Show initiative and direction in new company processes
• Responsible for site contract payments and proactive float management
• Support audits and ensure continuous eTMF quality.
• Provide proactive team support by identifying bottlenecks, participating in process improvement initiatives, and contributing to department-wide optimisation projects.

Qualifications & Skills

• Excellent written and oral communication skills in English. Understanding of international cultures.
• Work with international sponsors and partners, building strong global communication skills.
• Strong organisational skills and exceptional attention to detail
• Proficiency in MS Office (especially MS Project) and general IT/database systems.
• Ability to understand and escalate challenges effectively.
• Experience with Florence, Veeva eTMF platforms amongst others is an advantage.
• Proficiency in CTMS updates and maintaining accurate records.
• Experience coordinating early-phase (FIH, Phase I & II) trial activities, including safety reporting and intensive data monitoring.
• Advanced knowledge of ethics and regulatory processes specific to early-phase and high-complexity studies.
• Strong ability to manage high-volume document tracking and tight timelines.
• Confidence in proactively coordinating multiple clinical sites and supporting site initiation.
• Experience with investigator meetings preparation and logistical support.
• Familiarity with pharmacovigilance processes and serious adverse event (SAE) tracking.
• Critical thinking and strong problem-solving skills to handle operational challenges common in early-phase trials.
• Deep understanding of the clinical trial life cycle, especially for Phase I and II studies.
• Ability to work on own initiative and demonstrate a high level of autonomy.
• Proficient in taking detailed and accurate meeting minutes and tracking action items.
• Ability to mentor and train our team and support their professional development.
• Possess a keen eye for detail and commitment to maintaining high standards of quality and compliance
• Ability to coordinate with multiple stakeholders and adapt to shifting project needs.
• Applicants must have at least 2 years of experience within a CRO environment. This is essential to ensure you can hit the ground running and act as a super user across our various clinical systems and platforms.
• Must be based in Australia, have full working rights, and be ready to work from home or on-site in the Melbourne office as needed.

Why SAPRO CRO?

At SAPRO, we pride ourselves on being a close-knit, forward-thinking team. We support niche biotech and medtech innovators, and our work directly contributes to improving patients' lives. You'll have opportunities to grow your career, work on meaningful projects, and be part of a company that values integrity, agility, and collaboration.

Research us and our vibe:

Ready to make an impact?

To apply, please email your CV with either a cover letter or a link to a short introduction video outlining your suitability for the role to - Apply today and help shape the future of clinical research with us.