Clinical Research Associate I

• Monitor activities conducted by clinical investigative sites for AbbVie clinical studies
• Ensure protocol execution, regulatory compliance, GCP/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 motivate or influence them to meet study objectives
• Proactively manage sites and implement action plans to ensure compliance and inspection readiness
• Ensure quality and timely submission of study-site data, including safety-event reporting and follow-up
• Ensure study-subject safety and protection through monitoring-plan, SOP, guideline, and regulatory compliance
• Train study-site personnel on protocols and regulatory requirements
• Manage investigator payments and negotiate investigator/hospital agreements
• Complete expense reports according to applicable guidelines
• Identify, evaluate, and recommend potential investigators and clinical sites

• Appropriate tertiary qualification in a health-related field (e.g., Medical, Scientific, Nursing) preferred
• Clinical Trials Master’s Degree preferred
• Minimum of 1 year of clinically related experience
• Preferably 6 months of independent clinical research monitoring or Study Coordinator experience
• Experience in on-site monitoring of investigational drug or device trials required
• In-depth knowledge of therapeutic indications relevant to clinical trials
• 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
• Interpersonal skills and ability to communicate clearly
• Ability to address clinical site issues with appropriate guidance and initiate and communicate corrective action
• Ability to use functional expertise and exercise good judgment

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