Job Description:

• Advance AbbVie’s clinical research pipeline and turn science into medicine for patients
• Serve as the primary point of contact for investigative sites
• Provide clinical trial context 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, AbbVie SOPs, and quality standards
• Develop and customize site engagement strategies
• Gather site insights and use CRM tools to track progress and measure impact
• Support clinical trial execution and protocol compliance
• Evaluate recruitment and retention techniques based on the patient disease journey
• Develop therapeutic-area, asset, clinical-landscape, and patient-journey knowledge
• Mentor and train less experienced CRAs
• Participate in global or local task forces and initiatives
• Conduct continuous risk assessment with the Central Monitoring team
• Monitor clinical sites for study-performance and patient-safety issues
• Implement preventative and corrective action plans to mitigate risk and promote compliance
• Identify, evaluate, and recommend investigators and sites
• Ensure timely, accurate data submission and safety-event reporting
• Maintain audit and regulatory inspection readiness
• Manage investigator payments as required by executed contracts

Requirements:

• Appropriate tertiary qualification 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 for investigational drug or device trials
• Familiarity with risk-based monitoring, onsite and offsite 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 work effectively in a dynamic environment with competing projects and deadlines
• Ability to leverage technology, tools, and resources for customer-centric support
• Strong interpersonal, written, verbal, active listening, and presentation skills
• Ability to establish and leverage site relationships and trusted partnerships through engagement, motivation, and training
• Critical thinking and good judgment to address clinical site issues
• Ability to act with integrity in accordance with AbbVie’s code of business conduct and leadership values
• Self-motivated approach focused on timely, quality outcomes in a fast-paced environment
• Willingness and ability to travel 75% of the time

Benefits:

• Paid time off, including vacation, holidays, and sick leave
• Medical, dental, and vision insurance
• 401(k)
• Eligibility to participate in short-term incentive programs
• Travel opportunities (role requires travel 75% of the time)