Senior Clinical Research Associate

• Ensure successful protocol-level execution of SMM deliverables for assigned sites/studies, including start-up, execution, and close-out
• Conduct monitoring visits, site evaluations, site selection and activation, monitoring close-out, and visit reports
• Anticipate and resolve site issues affecting timelines
• Maintain current site-specific information in clinical trial management systems
• Provide local regulatory and legal requirement expertise
• Ensure timely site payments according to clinical study agreements and local requirements
• Ensure adherence to regulations, GCPs, ICH Guidelines, SOPs, monitoring plans, and quality standards
• Maintain audit and inspection readiness; support audits, inspections, and CAPA preparation
• Coach and mentor CRAs and contribute to their development
• Serve as country point of contact for CROs when assigned
• Participate in or lead global/local task forces and initiatives
• Identify training needs and standardize or facilitate global SMM monitor training when assigned
• Support onboarding and incorporate lessons learned into monitoring training materials and curricula when assigned
• Update country-level planning information in Impact/Tesla when assigned
• Collaborate with stakeholders as a global study representative when assigned
• Conduct remote data review according to study plans, SOPs, timelines, and objectives when assigned
• Provide ongoing site-performance feedback
• Build professional and collaborative relationships with peers and site monitors

• Bachelor's or equivalent degree, health related (e.g. Medical, Scientific, Nursing, Pharmacy) preferred
• Minimum 3 years of site monitoring experience
• Strong analytical and critical thinking skills
• Excellent interpersonal skills and clear, persuasive communication
• Flexibility and adaptability to changing requirements
• Resourcefulness and creativity
• Proactive and positive team-player approach
• Strong planning and organizational skills
• High level of flexibility in a dynamic environment with competing projects and deadlines
• Business ethics and integrity
• Knowledge of federal and local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie SOPs, and monitoring plans

• Employees can work remotely
• Equal opportunity employer
• Veterans/Disabled employment commitment