Graduate Certificate of Clinical Trial Operations

• You will be able to explain the principles and concepts of the biological, epidemiological and clinical sciences and apply this advanced theoretical and technical knowledge to the implementation and management of clinical trials. (An applied scientist – Capability 1 Scientist and Scholar)
• You will be able to analyse, generate and transmit solutions to complex problems, formulate research questions, critically evaluate and interpret scientific literature and evidence to inform management of clinical trial participants and research data generation. (A research-informed scholar - Capability 1 Scientist and Scholar)
• You will be able to demonstrate advanced cognitive and communication skills to transmit knowledge, skills and ideas to all stakeholders involved including study participants in diverse settings and communication channels. (An effective personal and digital communicator - Capability 2 Practitioner)
• You will be able to demonstrate safe, effective, patient-centred clinical reasoning, and identify and report adverse events at a level that meets the standards and requirements of national and international guidelines and regulations. (A patient-centred and safe practitioner - Capability 2 Practitioner) 
• You will be able to discuss the need and demonstrate culturally respectful care for diverse cultures and populations, including Aboriginal and Torres Strait Islander people during clinical trial activities (A socially and culturally versatile professional- Capability 3. Engaged Global Citizen).
• You will be able to discuss epidemiological concepts, health economics and apply current knowledge and skills of a range of therapeutic areas, to care for individuals at risk and promote health in clinical trials. (A public health and systems-aware practitioner - Capability 3. Engaged Global Citizen) 
• You will be able to apply knowledge and skills to demonstrate autonomy, well-developed judgement, adaptability and responsibility as a learner and a professional in multidisciplinary teams undertaking clinical trials as a leader and a collaborator. (A team worker- Capability 4 Professional)
• You will be able to adhere to the high ethical and legal standards required in clinical trials conduct, work within their professional scope of practice and demonstrate self-care and a reflective approach to practice and learning. (An ethical and reflective professional - Capability 4 Professional)

Clinical trials are a fundamental part of evidence-based medical research, as they serve to evaluate the safety and effectiveness of new interventions, medications, vaccines, devices and diagnostic tests. They’ve played a key role in the discovery of new treatments for many diseases, and they underpin regulatory approvals around the world. Currently, there’s a critical shortage of skilled staff in the clinical trials sector, and growing this workforce has been deemed a key priority by the Australian Government.

The Graduate Certificate of Clinical Trials Operations is co-designed with industry to meet the growing demand for formally accredited professionals to work in the sector. Via practical, work-related teaching and assessment combined with the study of contemporary local and global issues, you’ll gain the capabilities required by employers to deliver and manage safe, patient-centred clinical trials and produce credible data.

Recommended study pattern

Foundations of Clinical Trials

Clinical Trial Operations

Clinical Trial Management

Advanced Clinical Trial Skills

Open Universities Australia is a not-for-profit organisation. You will not pay any fees for using our services.

Indicative total fee $15,900

The amounts shown here are indicative for an Australian citizen studying full-time, which is typically 8 subjects per year.

Fees may vary depending on:

• the subjects you choose
• credit from previous work experience
• your eligibility for government funding loans or subsidies such as HECS-HELP or a Commonwealth supported place.

To learn more, go to Fees or contact a student advisor.

his research-intensive university in north-western Sydney offers a range of undergraduate and postgraduate degrees.

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QS World University Ranking 2026, within Australia:

11

Times Higher Education World University Ranking 2026, within Australia:

9

AQF level 7 bachelor’s qualification, or recognised equivalent with a WAM of 65.