Senior Clinical Research Associate

• Serve as the primary sponsor point of contact for investigative sites
• Provide contextual information on clinical trials and connect stakeholders with investigative sites
• Align, train, and motivate site staff and principal investigators on trial goals, protocols, and patient treatment principles
• Support, guide, and mentor junior personnel on site management activities
• Conduct site evaluation, site training, routine on-site and off-site monitoring, and site closure monitoring
• Ensure compliance with protocols, monitoring plans, regulations, GCP, ICH Guidelines, AbbVie SOPs, and quality standards
• Develop and customize site engagement strategies and track their progress and impact
• Apply scientific principles, clinical trial requirements, and therapeutic-area knowledge to trial execution
• Generate recruitment and retention techniques and plans based on the patient disease journey
• Mentor and train less experienced CRAs and support local onboarding
• Participate in or lead global and local task forces and initiatives
• Conduct continuous risk assessment with the Central Monitoring team to identify study performance or patient safety issues
• Resolve site risk signals and implement preventative and corrective action plans
• Identify, evaluate, and recommend potential investigators and sites
• Ensure quality and timely submission of site data and safety-event reporting
• Maintain audit and regulatory inspection readiness at assigned sites
• Manage investigator payments according to executed contract obligations, as applicable

• Appropriate tertiary qualification in health related disciplines (e.g., Medical, Scientific, Pharmacy, Nursing) preferred
• Minimum of 3 years of clinically related experience
• 2 years preferable in independent clinical research monitoring of investigational drug or device trials
• Familiarity with risk-based monitoring approach, onsite and offsite monitoring
• Knowledge of appropriate therapeutic area indications and scientific concepts related to clinical trials
• Superior knowledge of local regulatory and legal requirements, ICH/GCP Guidelines, and applicable policies
• Advanced communication and cross-functional collaboration skills
• Superior planning and organizational skills
• Ability to work effectively in a dynamic environment with competing projects and deadlines
• Ability to leverage technology, tools, and resources to provide customer-centric site support
• Superior written, verbal, active listening, presentation, and interpersonal skills
• Ability to establish and leverage site relationships and trusted partnerships
• Ability to independently address clinical site issues using functional expertise, critical thinking, and good judgment
• Integrity in accordance with AbbVie code of business conduct and leadership values
• Self-motivated focus on timely, quality outcomes in a fast-paced environment

• Remote work option
• Equal opportunity employment
• Reasonable accommodations for US & Puerto Rico applicants
• Veteran and disability-inclusive employment practices