Quality Assurance (QA) Associate

The Opportunity  

 The team at Doherty Clinical Trials are driven to expand the horizons of early phase clinical trials, human challenge trials and medical research through the delivery of high quality and safe clinical trials. We foster collaboration with stakeholders and value the essential role of clinical trial volunteers, to enable groundbreaking, innovative medical research that will translate to vaccines and therapies, especially for infectious diseases.

The Role 

 The Quality Assurance (QA) Associate will be responsible for supporting the oversight and continuous improvement of the Quality Management System (QMS) and ensuring clinical trial activities are conducted in accordance with approved protocols, ICH GCP, internal procedures and other applicable regulatory requirements. The QA Associate will work closely with all operational teams to identify quality risks, support investigations into deviations and CAPAs, conduct internal audits and contribute to inspection and audit readiness.

About You 

 This role is particularly focused on supporting the quality delivery of early-phase and Phase 1 clinical trials, where participant safety, data integrity, protocol compliance and rapid identification and escalation of quality risks are critical.  You will be planned and considered in your approach, and work collaboratively with operational teams to ensure that DCT clinical trials are conducted to a high standard of quality and compliant with relevant requirements.  You will be self-motivated and have demonstrated high level of initiative. The early-phase and Phase 1 environment is a fast paced one and you will be agile in your approach, prioritising clinical trials needs to ensure compliance study delivery.  You will also play an active role in staff training initiatives to foster a strong culture of quality across the organisation.

You will possess:

• Excellent communication and collaboration skills, with the ability to engage effectively with internal teams, sponsor representatives, and external research partners.

• Strong written skills, with the ability to prepare clear and concise documentation on clinical trial protocols, procedures, and safety guidelines.

• A solid understanding of QMS, including risk management, internal audits, deviation handling, CAPA management, and document control.

• A proactive approach to promoting compliance, safety, and continuous improvement in clinical research settings.

• High attention to detail, strong problem-solving skills, and the ability to work independently with initiative.

• A collaborative mindset and the willingness to support and guide clinical trial staff on best practice in a team-based environment.

• National Police Check or willing to undertake

Desirable Skills:

• Familiarity with key regulatory frameworks such as ISO, ICH-GCP, TGA, FDA, EMA, and Australian Ethics and Clinical Trials Guidelines.

• Clinical trial experience is highly desirable.

 To protect the health and safety of participants, staff and other healthcare workers, vaccination for certain diseases is highly recommended for staff.

 Shortlisting will commence immediately, so please send your application without delay.

Applications close 18th of September 2026.

 To arrange a confidential conversation please email ••••@theengagedspace.com.au