Senior Clinical Research Associate

• Execute protocol-level SMM deliverables for assigned sites and studies across start-up, execution, and close-out
• Conduct monitoring visits, site evaluations, site selection and activation, monitoring close-out, and visit reporting
• Anticipate and resolve site issues affecting timelines
• Maintain current clinical trial management systems with site-specific information
• Provide expertise on local regulatory and legal requirements
• Ensure timely payment execution for assigned sites and studies
• Ensure adherence to regulations, GCPs, ICH Guidelines, SOPs, Monitoring Plans, and quality standards
• Stay current on evolving local regulations, guidelines, and policies
• Ensure audit and inspection readiness; advise on pre-audit GCP activities
• Prepare and follow up on site audits and inspections and provide input into 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 and local task forces and initiatives
• Identify training needs and standardize and facilitate training solutions for SMM monitors when assigned
• Support onboarding and consolidate lessons learned into monitoring training materials and best-practice curricula when assigned
• Serve as a country or district study contact when assigned
• Update Impact/Tesla with country-level planning information and LSR assignments when assigned
• Act as global representative for studies when assigned
• Conduct remote data review according to IDRP, Monitoring Plan, SOP/WI, timelines, and study objectives when assigned
• Provide ongoing feedback on investigator and site performance
• Build professional and collaborative relationships with peers and site monitors

• Bachelor's or equivalent degree in a health-related field (e.g. Medical, Scientific, Nursing, Pharmacy) preferred
• Minimum 3 years of site monitoring experience
• Strong analytical and critical thinking skills
• Excellent interpersonal and persuasive communication skills
• 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
• Demonstrated business ethics and integrity
• Compliance with federal and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie SOPs, Monitoring Plans, and quality standards
• Knowledge of local regulatory and legal requirements
• Ability to ensure audit and inspection readiness

• Remote work availability
• Equal opportunity employer
• Commitment to operating with integrity, driving innovation, transforming lives, and serving the community