Clinical Trial Assistant

Job Description: Clinical Trial Assistant (CRO Experience)

Position Title: Clinical Trial Assistant (CTA)

Location: Melbourne (Remote/Hybrid/On-site options available)

Employment Type: 1 day per week with potential to build to full time.

About the Role

Avion are an Australian owned, boutique, end-to end full-service specialist CRO services provider aimed at supporting biotechnology, pharmaceutical, medical technology and device companies to undertake their clinical development programs both in Australia and around the world. Our aim is to innovate today to transform tomorrow's healthcare to improve patient outcomes:

We have an exciting opportunity to join our collaborative team and are currently seeking a detail-oriented and proactive Clinical Trial Assistant (CTA) with prior experience in a Contract Research Organization (CRO). As a CTA, you will provide essential support for the planning, execution, and management of clinical trials across various phases. You will play a key role in ensuring the smooth operation of trials, assisting cross-functional teams, and maintaining compliance with regulatory standards.

Key Responsibilities

Clinical Trial Support:

• Assist in the preparation, tracking, and management of essential trial documentation, including trial master files (TMF), regulatory documents, and study binders.
• Support the coordination of clinical trial activities, including investigator meetings, study site communications, and monitoring visits.

· Maintain and update study trackers, ensuring the timely documentation of study milestones.

· Work closely within a multidisciplinary team of Clinical Research professionals

· Assist in study budget and expense management, including oversight of site & vendor payments and budget tracking

Regulatory and Compliance:

• Ensure the timely submission and archiving of trial-related documents in compliance with GCP, ICH guidelines, and sponsor/CRO requirements.
• Collaborate with regulatory teams to collect and organize essential site documentation, such as investigator agreements and ethics committee approvals.

Site Management Support:

• Act as a central point of contact for clinical sites, study teams, and vendors to facilitate communication and resolve queries.
• Coordinate the shipment and tracking of study supplies, investigational products, and related materials.

Data and Reporting:

• Assist in the collection and review of site data to ensure consistency, accuracy, and completeness.
• Generate and distribute reports on trial progress, metrics, and compliance for internal and external stakeholders.

Administrative Duties:

• Schedule and organize meetings, teleconferences, and training sessions for study teams and investigators.
• Maintain and manage electronic and paper-based filing systems for trial documents.
• Provide administrative support to Clinical Research Associates (CRAs) and Project Managers as needed.

Qualifications

Education and Experience:

• Bachelor's degree in Life Sciences, Health Sciences, or a related field.
• At least 2 years of experience in clinical trial support roles within a CRO or similar environment.

Technical Skills:

• Proficiency in clinical trial management systems (CTMS) and electronic trial master file (eTMF) platforms.
• Understanding of GCP, ICH guidelines, and clinical trial regulatory requirements.
• Strong organizational and multitasking abilities, with attention to detail.
• Comfortable setting up budget tracking
• Invoice and budget tracking for clinical trials specifically

Soft Skills:

• Excellent communication and interpersonal skills to work effectively with internal and external stakeholders.

· Ability to prioritize tasks and work under tight timelines in a fast-paced environment.

· Ability to work independently with a high-level of initiative as well as an ability to work well as part of a team

Preferred Qualifications:

• Familiarity with industry-standard tools such as EDC systems and document management software.
• Experience in coordinating multiple clinical trials across therapeutic areas.

Why Join Us?

• Opportunity to work with a leading Contract Research Organization on cutting-edge clinical trials.
• Collaborative and innovative work culture with opportunities for career advancement.

· Competitive compensation package, including benefits and professional development opportunities.

· We offer hybrid working arrangements and flexibility in working hours to ensure our staff achieve the work-life balance often missing in this role.