Senior Clinical Research Associate

• Advance AbbVie’s oncology clinical research pipeline and support innovative medicines and solutions
• 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
• Support, guide, and mentor junior personnel and CRAs on site-management activities
• Conduct site evaluation, site training, routine onsite/offsite monitoring, and site-closure monitoring
• Ensure compliance with protocols, monitoring plans, regulations, GCP, ICH Guidelines, SOPs, and quality standards
• Develop and customize site-engagement strategies; gather site insights and track strategy impact
• Develop recruitment and retention techniques based on the patient disease journey
• Participate in or lead global/local task forces and initiatives
• Conduct continuous risk assessment with the Central Monitoring team and address site risk signals
• Implement preventative and corrective action plans to mitigate risk and promote compliance
• 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

• Minimum of 3 years of clinically related experience
• Preferably 2 years of independent clinical research monitoring experience for investigational drug or device trials
• Appropriate tertiary qualification in a health-related discipline (e.g., Medical, Scientific, Pharmacy, Nursing) preferred
• Familiarity with risk-based monitoring and onsite/offsite monitoring
• Knowledge of therapeutic-area indications and scientific concepts relevant 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 manage 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 independently address clinical site issues using functional expertise, critical thinking, and judgment
• Integrity consistent with AbbVie’s 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