AbbVie is a global pharmaceutical company focused on discovering, developing, and delivering medicines for complex health conditions. Its portfolio spans immunology, oncology, neuroscience, and aesthetics, with operations serving patients in more than 175 countries. The company’s work combines pharmaceutical research, manufacturing, and healthcare expertise, supported by substantial investment in scientific innovation and research and development. AbbVie also highlights diversity, sustainability, and patient support as part of its broader approach to improving health outcomes and community impact.
AbbVie Clinical Research Associate II - Australia Remote
AbbVie is hiring a Clinical Research Associate II to monitor clinical trials across Australia. The role supports investigative sites, patient safety, recruitment, regulatory compliance, and study delivery.
Description
- Serve as the primary sponsor contact for investigative sites
- Share clinical trial information and connect relevant stakeholders with site teams
- Align, train, and motivate site personnel and principal investigators on study objectives, protocols, and patient treatment principles
- Perform site evaluations, training visits, routine onsite and remote monitoring, and close-out monitoring
- Maintain compliance with regulations, GCP, ICH guidelines, AbbVie procedures, monitoring plans, and quality standards
- Create and tailor strategies for engaging investigative sites
- Collect site feedback and measure the progress and impact of engagement strategies
- Translate protocol requirements, scientific principles, and clinical trial expectations into effective study execution
- Assess recruitment and retention approaches in the context of patient disease journeys
- Build knowledge of the therapeutic area, development asset, clinical landscape, and patient journeys
- Coach and train less experienced clinical research associates
- Contribute to global and local task forces and improvement initiatives
- Perform ongoing risk assessments with the Central Monitoring team
- Address site risk signals and put preventive and corrective action plans into practice
- Identify and assess prospective investigators and investigative sites
- Ensure site data and safety-event reports are submitted accurately and on time
- Keep sites prepared for audits and regulatory inspections
- Administer investigator payments where applicable under executed contracts
- Report adverse events within 24 hours in line with AbbVie policy
- Take part in workplace health and safety programs
- Follow AbbVie codes of conduct and ethical standards
- Handle additional administrative tasks as needed
Requirements
- Bachelor’s degree or equivalent qualification, preferably in a health-related discipline such as medicine, science, nursing, or pharmacy
- At least one year of clinically related experience
- At least six months of clinical research monitoring experience in investigational drug or device trials
- Experience with healthy volunteer and first-in-patient studies is highly desirable
- Familiarity with risk-based, onsite, and remote monitoring practices
- Strong ability to collaborate across functions
- Strong planning and organizational capabilities
- Ability to work efficiently in a changing environment while managing competing projects and deadlines
- Advanced ability to use technology, tools, and available resources effectively
- Strong interpersonal, written, verbal, active listening, and presentation skills
- Ability to develop site relationships and trusted partnerships
- Ability to apply functional expertise, critical thinking, and sound judgment to clinical site issues
- Self-directed approach with a focus on timely, high-quality results
- Knowledge of relevant therapeutic indications and the scientific concepts underpinning clinical trials
- Advanced knowledge of applicable local regulatory and legal requirements, ICH/GCP guidelines, and organizational policies
- Availability to occasionally attend business meetings outside standard working hours
Benefits
- Remote work is available
- Flexible and supportive working environment
- Flexible, accessible recruitment process
- Workplace accommodations are available on request
- Right to disconnect outside working hours in accordance with Australian legislation
- Some flexibility may be required for business meetings outside standard hours
- Inclusive workplace with equal employment opportunities