Senior Clinical Research Associate

• Advance AbbVie's clinical research pipeline by supporting excellence in clinical research
• Partner with study teams, internal R&D stakeholders, investigators and site staff
• Serve as the primary sponsor point of contact for the investigative site
• Align, train and motivate site staff and principal investigators on trial goals, protocols and patient treatment principles
• Support, guide and mentor junior personnel and CRAs 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, SOPs and quality standards
• Customize site engagement strategies and track progress and impact using site engagement tools
• Apply protocol, scientific and clinical trial knowledge to day-to-day trial execution
• Develop recruitment and retention techniques based on the patient disease journey
• Build knowledge of the therapeutic area, asset, clinical landscape and patient journey
• Participate in or lead global and local task forces and initiatives
• Conduct continuous risk assessment in collaboration with the Central Monitoring team
• 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 contracts, as applicable

• Appropriate tertiary qualification in health related disciplines (e.g., Medical, Scientific, Pharmacy, Nursing) preferred
• Minimum of 3 years of clinically related experience
• Preferably 2 years of independent clinical research monitoring of investigational drug or device trials
• Familiarity with risk-based monitoring approach, onsite and offsite monitoring
• Knowledge of therapeutic area indications and ability to apply scientific concepts to clinical trials
• 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 for customer-centric site support
• Superior written, verbal, active listening and presentation 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
• Acts with integrity in accordance with AbbVie code of business conduct and leadership values
• Self-motivated and focused on timely, quality outcomes

• Employees can work remotely
• Equal opportunity employer
• Commitment to operating with integrity, driving innovation, transforming lives and serving the community