Clinical Research Associate II

• Act as the primary Sponsor point of contact for investigative sites
• Provide contextual information on clinical trials 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 on-site and off-site monitoring, and site closure monitoring
• Ensure compliance with regulations, GCPs, ICH Guidelines, AbbVie SOPs and quality standards
• Develop and customise site engagement strategies; gather local/site insights and track strategy impact
• Connect study protocols and scientific principles to day-to-day trial execution
• Evaluate and ensure recruitment and retention techniques based on the patient disease journey
• Develop therapeutic area, asset, clinical landscape and patient journey knowledge to support recruitment and protocol compliance
• Mentor and train less experienced CRAs
• Participate in global/local task forces and initiatives
• Perform continuous risk assessment and collaborate with Central Monitoring to identify study performance or patient safety issues
• Resolve site risk signals and implement preventative and corrective action plans
• Identify, evaluate and recommend investigators and sites for clinical studies
• Ensure quality and timely submission of site data, including safety-event reporting and follow-up
• Maintain audit and regulatory inspection readiness at assigned clinical sites
• Manage investigator payments as required by executed contracts
• Report adverse events within 24 hours according to AbbVie policies
• Participate in WHS programs and promote a safe work environment
• Adhere to AbbVie codes of conduct, compliance processes and required training
• Perform other administrative and ad hoc duties as requested

• 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 in investigational drug or device trials
• Experience in Healthy Volunteer and First in Patient trials highly desirable
• Familiarity with risk-based monitoring approach, onsite and offsite monitoring
• Strong cross-functional collaboration skills
• Strong planning and organisational skills; ability to work effectively 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 apply critical thinking and good judgement to clinical site issues
• Knowledge of appropriate 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 participate occasionally in business meetings outside standard hours when reasonably required for global collaboration
• Acts with integrity in accordance with AbbVie code of business conduct and leadership values

• Flexible and supportive workplace
• Flexible and accessible hiring process
• Reasonable accessibility adjustments/accommodations available
• Right to disconnect protections under Australia's legislation
• Support for occasional flexibility in working hours for global collaboration