YOUR NEXT CHAPTER
Clinical Research Associate II
About the role
• Advance AbbVie’s clinical pipeline through excellence in clinical research
• Partner with investigators and site staff to support meaningful clinical-trial engagements
• Serve as the primary 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 monitoring, and site-closure activities in compliance with protocols, monitoring plans, regulations, GCP, ICH Guidelines, SOPs, and quality standards
• Develop and customize site-engagement strategies for assigned studies
• Gather local and site insights and use CRM tools to track progress and measure impact
• 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/local task forces and initiatives as assigned
• 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 potential investigators and sites
• Ensure data quality and timely submission, including safety-event reporting and follow-up
• Maintain audit and regulatory inspection readiness at assigned sites
• Manage investigator payments according to executed contract obligations, as applicable
• Minimum of 1 year of clinically related experience
• At least 6 months of clinical research monitoring of investigational drug or device trials
• Familiarity with risk-based monitoring approach, onsite and offsite monitoring
• Knowledge of appropriate therapeutic area indications preferred
• Advanced knowledge of local regulatory and legal requirements, ICH/GCP Guidelines, and applicable policies
• Strong cross-functional collaboration skills among internal and external stakeholders
• Strong planning and organizational skills; ability to work effectively in a dynamic environment with competing projects and deadlines
• Advanced ability to leverage technology, tools, and resources for customer-centric site support
• Strong interpersonal skills with excellent written, verbal, active listening, and presentation skills
• Ability to establish and leverage site relationships and trusted partnerships through engagement, motivation, and training
• Ability to use functional expertise, critical thinking, and good judgment to address clinical site issues
• Acts with integrity in accordance with AbbVie code of business conduct and leadership values
• Self-motivated and focused on delivering timely, quality outcomes
• Appropriate tertiary qualification in a health-related discipline (Medical, Scientific, Nursing) preferred
• Employees can work remotely
• Equal opportunity employer
• Reasonable accommodation for US & Puerto Rico applicants