Senior Clinical Research Associate

• Advance AbbVie's oncology clinical research pipeline and support innovative medicines
• Partner with study teams, internal R&D stakeholders, investigators and site staff
• Serve as the primary sponsor point of contact for investigative sites
• Align, train and motivate site staff and principal investigators on trial goals, protocols and patient treatment principles
• Mentor and support 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, AbbVie SOPs and quality standards
• Develop and customize site engagement strategies; gather site insights and track strategy impact
• Generate and implement patient recruitment and retention techniques based on the disease journey
• Develop knowledge of the oncology therapeutic area, asset, clinical landscape and patient journey
• Participate in or lead global and local task forces and initiatives
• Conduct continuous risk assessment 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 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
• At least 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 therapeutic area indications and ability to understand and 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 and efficiently in a dynamic environment with competing projects and deadlines
• Ability to leverage technology, tools and resources for customer-centric site support
• Superior interpersonal, written, verbal, active listening and presentation skills
• Ability to establish and leverage site relationships and trusted partnerships
• Ability to independently use functional expertise, critical thinking and judgment to address clinical site issues
• Integrity in accordance with AbbVie code of business conduct and leadership values
• Self-motivated and focused on timely, quality outcomes in a fast-paced environment

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