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Clinical Research Associate II

Sobre el puesto

• Serve as the primary 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
• Conduct site evaluation, site training, routine monitoring, and site closure activities
• Ensure compliance with protocols, monitoring plans, regulations, GCPs, ICH Guidelines, SOPs, and quality standards
• Develop and customize site engagement strategies for assigned studies
• Gather local and site insights and use CRM tools to track progress and measure impact
• Connect study protocols, scientific principles, and clinical trial requirements to daily trial execution
• Evaluate and ensure recruitment and retention techniques based on the patient disease journey
• Develop therapeutic-area, asset, clinical-landscape, and patient-journey knowledge to support recruitment and protocol compliance
• Mentor and train less experienced CRAs and contribute to their development
• Participate in global and local task forces and initiatives
• Conduct continuous risk assessment with the Central Monitoring team to identify study-performance and patient-safety issues
• Resolve site risk signals and implement preventative and corrective action plans
• Identify, evaluate, and recommend investigators and sites for clinical studies
• Ensure quality and timely submission of site data, including safety-event reporting and follow-up
• Maintain audit and regulatory inspection readiness at assigned sites
• Manage investigator payments according to executed contract obligations, as applicable

• Bachelor's Degree in health-related disciplines (Medical, Scientific, Nursing) preferred
• Minimum of 1 year of clinically related experience
• At least 6 months of clinical research monitoring experience involving investigational drug or device trials
• Familiarity with risk-based monitoring approaches, including onsite and off-site monitoring
• Knowledge of applicable therapeutic area indications preferred
• Advanced knowledge of local regulatory and legal requirements, ICH/GCP Guidelines, and applicable policies
• Strong cross-functional collaboration skills
• Strong planning and organizational skills; ability to manage competing projects and deadlines
• Ability to leverage technology, tools, and resources for customer-centric site support
• Strong interpersonal, written, verbal, active listening, and presentation skills
• Ability to establish and leverage site relationships and partnerships through engagement, motivation, and training
• Ability to apply critical thinking and good judgment to clinical site issues
• Integrity consistent with AbbVie’s code of business conduct and leadership values
• Self-motivated approach focused on timely, quality outcomes
• Regular driving required
• Eligibility to operate a company vehicle, subject to applicable AbbVie policies and procedures

• Paid time off, including vacation, holidays, and sick leave
• Medical, dental, and vision insurance
• 401(k)
• Eligibility to participate in short-term incentive programs
• Company vehicle eligibility, subject to applicable policies and procedures