Clinical Research Associate II

• Act as the primary Sponsor point of contact for investigative sites
• Provide clinical-trial context 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 and quality standards
• Develop and customise site-engagement strategies for assigned studies
• Gather site insights and track engagement progress and impact
• Connect study protocols and scientific principles to day-to-day trial execution
• Evaluate recruitment and retention techniques based on the patient disease journey
• 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 recommend qualified investigators and sites
• Ensure quality and timely submission of site data and safety-event reporting
• Maintain audit and regulatory inspection readiness
• Manage investigator payments as applicable
• Report adverse events within 24 hours
• Participate in AbbVie’s WHS programs and 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 in 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
• Advanced ability to leverage technology, tools and resources
• Strong written, verbal, active listening and presentation skills
• Ability to establish and leverage site relationships and trusted partnerships
• Critical thinking and good judgement to address clinical site issues
• Knowledge of therapeutic area indications and scientific concepts relevant to clinical trials
• Advanced knowledge of local regulatory and legal requirements, ICH/GCP Guidelines and applicable policies
• Flexibility to occasionally participate in business meetings outside standard hours
• Adherence to AbbVie’s codes of conduct, ethics and compliance processes

• Flexible and supportive workplace
• Flexible and accessible hiring process
• Workplace accommodations for accessibility requirements
• Support for employees’ right to disconnect outside working hours, subject to reasonable exceptions
• Equal opportunity and inclusive workplace
• Professional development through mentoring and training opportunities