Clinical Research Associate

About Orygen

Orygen is recognized as Australia’s Centre of Excellence in Youth Mental Health and represents the world's largest translational research group devoted to youth mental health. For more than three decades, Orygen has pioneered early intervention strategies and created evidence-supported models of care to enhance mental health outcomes for individuals aged 12-25.

Position Overview

The Clinical Research Associate plays an essential role in ensuring Orygen’s research projects adhere to Good Clinical Practice (GCP) standards and maintain regulatory compliance. This position also involves assisting with the development and upkeep of the Quality Management System (QMS) and overseeing that all studies meet best-practice guidelines.

Primary Duties

• Conduct study monitoring and reporting activities as Sponsor CRA/monitor, including crafting risk-based monitoring plans, undertaking site visits, providing safety oversight, and managing close-out procedures for Orygen-sponsored studies.
• Offer regulatory and operational support by reviewing study documentation and advising investigators and study teams on compliance, study design, and industry best practices.
• Lead systems and quality assurance tasks such as managing serious breaches and CAPA processes, driving Standard Operating Procedure (SOP) development, and supporting electronic Trial Master File (eTMF) implementation.
• Ensure all site activities conform with Orygen’s Research Governance Framework to streamline operational research processes across governed sites.
• Support full clinical operations including study start-ups, investigational product setup, electronic Case Report Form (eCRF) data management, and post-approval reporting.

Required Skills and Experience

• A bachelor’s degree or equivalent qualification in Science, Life Sciences, or a related Healthcare discipline.
• Substantial experience in pharmaceutical companies, Contract Research Organizations (CROs), biotech firms, or academic/medical research environments, with comprehensive knowledge spanning study initiation, conduct, and close-out, including Teletrials.
• Strong familiarity with International Council for Harmonisation Good Clinical Practice (ICH GCP) guidelines, safety reporting, and quality system implementations such as QMS processes.
• Proficiency with electronic Case Report Forms platforms (for example, REDCap), Trial Master File management, and meticulous review of protocols, Participant Information and Consent Forms (PICFs), and related study documents.
• Detail-focused and collaborative professional aptitude, adept at managing multiple priorities under pressure, and skilled at forging and maintaining relationships with diverse stakeholders.

Benefits

• Annual salary ranging between $125,000 and $135,000 pro rata, accompanied by 12% superannuation contributions, $15,900 in not-for-profit salary packaging, and a $2,600 meals and entertainment card.
• The flexibility of a hybrid work arrangement, enabling a combination of remote work and on-site collaboration.
• Opportunity to significantly impact youth mental health in an engaging, youth-centered environment.
• Work in a cutting-edge facility designed with input from young people dedicated to advancing youth mental health.
• Chance to support Orygen’s mission toward positive societal change for young people.

Additional Information

• Location: Parkville, Victoria — with easy access to public transport options.
• The position is a 2-year contract, either full-time or part-time (0.8 to 1.0 Full-Time Equivalent considered).
• Applicants should be aware that the role may involve exposure to sensitive mental health materials, requiring emotional resilience.
• Diversity and inclusion commitments: Orygen encourages applications from First Nations peoples and is dedicated to cultivating culturally safe and inclusive workplaces.
• Child safety and compliance: Employment requires a valid Working With Children Check and a successful police check, in line with Orygen’s child-safe policies.