Clinical Research Associate II

• Act as the primary Sponsor point of contact for investigative sites
• Provide clinical trial information and connect stakeholders with investigative sites
• Align, train, and motivate site staff and principal investigators on trial goals, protocols, and patient treatment principles
• Conduct site evaluation, site training, routine onsite and offsite monitoring, and site closure monitoring
• Ensure compliance with regulations, GCPs, ICH Guidelines, AbbVie SOPs, monitoring plans, and quality standards
• Develop and customize site engagement strategies
• Gather site insights and track engagement strategy progress and impact
• Connect protocol, scientific principles, and clinical trial requirements to trial execution
• Evaluate recruitment and retention techniques based on patient disease journeys
• Develop therapeutic-area, asset, clinical landscape, and patient-journey knowledge
• Mentor and train less experienced CRAs
• Participate in global/local task forces and initiatives
• Conduct continuous risk assessment with the Central Monitoring team
• Resolve site risk signals and implement preventative and corrective action plans
• Identify and evaluate potential investigators and sites
• Ensure quality and timely submission of site data and safety-event reporting
• Maintain audit and regulatory inspection readiness
• Manage investigator payments according to executed contracts, as applicable
• Report adverse events within 24 hours according to AbbVie policies
• Participate in workplace health and safety programs
• Maintain compliance with AbbVie codes of conduct and ethics requirements
• Perform ad hoc administrative duties

• Bachelor’s degree or equivalent degree; health related preferred (e.g. Medical, Scientific, Nursing, Pharmacy)
• Minimum of 1 year of clinically related experience
• At least 6 months of clinical research monitoring experience for investigational drug or device trials
• Experience in Healthy Volunteer and First in Patient trials highly desirable
• Familiarity with risk-based monitoring, onsite and offsite monitoring
• Strong cross-functional collaboration skills
• Strong planning and organisational skills
• Ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines
• Advanced ability to leverage technology, tools and resources
• Strong interpersonal, written, verbal, active listening, and presentation skills
• Ability to establish and leverage site relationships and trusted partnerships
• Ability to use functional expertise, critical thinking, and good judgment to address clinical site issues
• Self-motivated and focused on timely, quality outcomes
• Knowledge of relevant therapeutic area indications and scientific concepts related to clinical trials
• Advanced knowledge of local regulatory and legal requirements, ICH/GCP Guidelines, and applicable policies
• Ability to occasionally participate in business meetings outside standard hours

• Employees can work remotely
• Flexible and supportive workplace
• Flexible and accessible hiring process
• Accessibility accommodations available upon request
• Right to disconnect outside working hours under Australia’s legislation
• Occasional flexibility for business meetings outside standard hours
• Equal opportunity and inclusive workplace