Senior Clinical Research Associate

• Ensure successful protocol-level execution of SMM deliverables for assigned sites/studies, including study start-up, execution, and close-out
• Conduct and oversee monitoring visits, site evaluations, site selection and activation, monitoring close-out, and visit reports
• Anticipate and identify site issues affecting timelines and develop alternative solutions
• Maintain current clinical trial management systems with site-specific information
• Provide local regulatory and legal requirement expertise
• Ensure timely payment execution for assigned sites/studies according to clinical study agreements and local requirements
• Ensure adherence to federal and local regulations, Good Clinical Practices, ICH Guidelines, AbbVie SOPs, Monitoring Plans, and quality standards
• Stay current on evolving local regulations, guidelines, and policies
• Ensure audit and inspection readiness of assigned sites
• Advise on pre-audit GCP activities and prepare/follow up on site audits and inspections, including input into CAPA preparation
• Coach and mentor CRAs and provide input into 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/facilitate training solutions for SMM monitors when assigned
• Support onboarding, consolidate lessons learned, develop best-practice training curricula, and maintain awareness of upcoming changes
• Serve as a country/district study contact and update country-level information in Impact/Tesla when assigned
• Act as global representative for assigned studies when assigned
• Conduct remote data review of assigned sites/studies according to IDRP, Monitoring Plan, SOP/WI, timelines, and objectives when assigned
• Provide ongoing feedback on investigator/site performance
• 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 5 years of site monitoring experience
• Strong analytical and critical thinking skills to evaluate complex issues from multiple perspectives and drive smart decision making
• Excellent interpersonal skills with the ability to communicate persuasively and with clarity
• Flexibility and adaptability to changing requirements
• Resourcefulness and creativity
• Demonstrated proactive and positive team player
• Strong planning and organizational skills
• High level of flexibility in a dynamic environment with competing projects and deadlines
• 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