Clinical Research Associate II

• Anticipate and proactively solve study-related clinical site issues
• Initiate, recommend, and communicate corrective actions for successful protocol execution
• Monitor clinical investigative sites for adherence to protocols, regulations, ICH/GCP 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
• 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
• Ensure appropriate reporting and follow-up for safety events
• Ensure safety and protection of study subjects
• Train study site personnel on protocols and regulatory requirements
• Manage investigator payments according to executed contracts
• Negotiate investigator and hospital agreements with stakeholders
• Complete expense reports according to local and applicable guidelines
• Identify, evaluate, and recommend new or potential investigators and clinical sites

• Bachelor’s degree in a scientific or related field
• Minimum of 1 year of clinically-related experience
• 6 months of clinical research monitoring experience preferred
• Experience in on-site monitoring of investigational drug or device trials required
• Fluent in English, both written and verbal
• 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 and communication skills
• Ability to address clinical site issues and initiate and communicate corrective action
• Ability to use functional expertise and exercise good judgment
• Demonstrated business ethics and integrity

• Employees can work remotely
• Equal opportunity employer
• Commitment to operating with integrity, driving innovation, transforming lives and serving the community