Clinical Research Associate II, Oncology – Field Role

• Advance AbbVie’s oncology clinical research pipeline and turn science into medicine
• Partner with study teams, internal R&D stakeholders, investigators and site staff
• Serve 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 onsite and offsite monitoring, and site closure monitoring
• Ensure compliance with protocols, monitoring plans, applicable regulations, GCPs, ICH Guidelines, AbbVie SOPs and quality standards
• Develop and customize site engagement strategies and track progress and impact using site engagement tools
• Apply clinical trial protocols and scientific principles to day-to-day trial execution
• Evaluate recruitment and retention techniques based on the patient disease journey
• Build therapeutic-area, asset, clinical-landscape and patient-journey knowledge to support recruitment and protocol compliance
• Mentor and train less experienced CRAs and contribute to their development
• Participate in global or local task forces and initiatives
• Conduct continuous risk assessment with the Central Monitoring team to identify study performance or patient safety issues
• Resolve site risk signals and implement preventative and corrective action plans
• Identify, evaluate and recommend new investigators and clinical sites
• 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 according to executed contract obligations, as applicable

• Bachelor’s degree or equivalent degree; health related preferred (e.g. Medical, Scientific, Nursing, Pharmacy)
• Valid driver’s license
• Minimum of 1 year of clinically related experience
• At least 6 months of clinical research monitoring experience involving investigational drug or device trials
• Familiarity with risk-based monitoring, onsite monitoring and offsite monitoring
• Knowledge of appropriate therapeutic area indications and ability to apply scientific concepts to clinical trials
• Advanced knowledge of local regulatory and legal requirements, ICH/GCP Guidelines and applicable policies
• Strong cross-functional collaboration skills
• Strong planning and organizational skills; ability to work effectively in a dynamic environment with competing projects and deadlines
• Ability to leverage technology, tools and resources for customer-centric site support
• Strong interpersonal, written, verbal, active listening and presentation skills
• Ability to establish site relationships and trusted partnerships through engagement, motivation and training
• Critical thinking and good judgment to address clinical site issues
• Integrity in accordance with AbbVie’s code of business conduct and leadership values
• Self-motivation and focus on timely, quality outcomes
• Willingness to travel 75% of the time

• Life assurance
• Medical plan
• Flexible benefits
• Company car
• Comprehensive total reward package including compensation, well-being and benefits
• Coverage under the B011 – CCNL Chemical-Pharmaceuticals Industry national collective bargaining agreement