Clinical Research Associate I

• Monitor activities at clinical investigative sites for AbbVie clinical studies
• Ensure protocol execution and adherence to federal and local regulations, GCP, ICH Guidelines, AbbVie SOPs, monitoring plans, and quality standards
• Conduct site qualification, initiation, interim monitoring, and study closeout visits for Phase 1–4 studies
• Oversee site personnel activities and influence them to meet study objectives
• Proactively manage sites and implement action plans to ensure compliance
• Ensure regulatory inspection readiness at assigned clinical sites
• Ensure quality and timely submission of study-site data, including safety-event reporting and follow-up
• Ensure study-subject safety and protection through monitoring-plan and regulatory compliance
• Train study-site personnel on protocols and regulatory requirements
• Manage investigator payments according to executed contract obligations
• Complete expense reports according to applicable guidelines
• Identify, evaluate, and recommend potential investigators and clinical sites
• Report adverse events within 24 hours according to AbbVie policies and procedures
• Participate in AbbVie WHS programs and promote a safe work environment
• Adhere to AbbVie codes of conduct and compliance processes
• Perform other ad hoc administrative duties as requested

• Appropriate tertiary qualification in a health-related field (e.g., Medical, Scientific, Nursing) preferred
• Minimum of 1 year of clinically related experience
• Preferably 6 months of clinical research monitoring experience
• Experience in on-site monitoring of investigational drug or device trials required
• Current in-depth knowledge of relevant therapeutic indications
• Current in-depth knowledge of clinical research regulations, ICH/GCP Guidelines, and applicable regulations
• Strong planning and organizational skills
• Ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines
• Ability to understand and follow work processes within the assigned function
• Strong analytical and conceptual capabilities
• Strong interpersonal and clear communication skills
• Ability to address clinical site issues with appropriate guidance and initiate and communicate corrective action
• Ability to use functional expertise and exercise good judgment
• Demonstrated business ethics and integrity
• Flexibility to occasionally participate in business meetings outside standard hours
• Ability to work in Australia

• Flexible and supportive workplace
• Flexible and accessible hiring process
• Reasonable accessibility adjustments/accommodations
• Right to refuse contact outside working hours under Australia’s 'Right to Disconnect' legislation, unless refusal is unreasonable
• Equal opportunity and inclusive workplace