Clinical Research Associate II

• Monitor clinical investigative site activities for AbbVie clinical studies and ensure protocol execution
• Ensure adherence to federal and local regulations, Good Clinical Practices, ICH Guidelines, AbbVie SOPs, Monitoring Plans, and quality standards
• Conduct site qualification, initiation, interim monitoring, and study closeout visits for Phase 1–4 studies
• Oversee site personnel activities and influence them to meet study objectives
• Proactively manage sites and implement action plans to ensure compliance
• Ensure regulatory inspection readiness at assigned clinical sites
• Ensure quality and timely submission of study-site data, including safety-event reporting and follow-up
• Ensure safety and protection of study subjects
• Train study-site personnel on protocols and regulatory requirements
• Manage investigator payments according to contract obligations
• Negotiate investigator and hospital agreements with stakeholders
• Complete expense reports according to local and applicable guidelines
• Identify, evaluate, and recommend investigators and clinical sites for planned studies

• Appropriate tertiary qualification, health related (e.g., Medical, Scientific, Nursing) preferred
• Minimum 3 years of site monitoring experience
• Experience in on-site monitoring of investigational drug or device trials required
• Current in-depth knowledge of therapeutic indications relevant to clinical trials
• Current in-depth knowledge of clinical research regulations, ICH/GCP Guidelines, and applicable regulations
• Strong planning and organizational skills
• Ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines
• Ability to understand and follow work processes within the assigned function
• Strong analytical and conceptual capabilities
• Strong interpersonal skills and ability to communicate with clarity
• Ability to address study-related clinical site issues, initiate corrective action, and communicate recommendations
• Ability to use functional expertise and exercise good judgment
• Demonstrated business ethics and integrity

• Remote work option
• Equal opportunity employer commitment
• Support for reasonable accommodations for US & Puerto Rico applicants