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About the role
Key responsibilities & impact- Advance AbbVie’s clinical development pipeline by supporting excellence in clinical research
- 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 monitoring
- Ensure compliance with protocols, monitoring plans, regulations, GCPs, ICH Guidelines, SOPs, and quality standards
- Develop and customize site engagement strategies for assigned studies
- Gather site insights and use CRM tools to report and track progress and measure impact
- Connect study protocols, scientific principles, and trial requirements to daily trial execution
- 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 and contribute to their development
- Participate in global or local task forces and initiatives
- Conduct continuous risk assessment with the Central Monitoring team
- Detect study-performance or patient-safety issues and resolve site risk signals
- Implement preventative and corrective action plans to mitigate risk and promote compliance
- Identify, evaluate, and recommend investigators and clinical 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 as applicable
Requirements
What you’ll need- Minimum of 1 year of clinically related experience
- At least 6 months of clinical research monitoring of investigational drug or device trials
- Familiarity with risk-based monitoring, onsite and offsite monitoring
- Advanced knowledge of local regulatory and legal requirements, ICH/GCP Guidelines, and applicable policies
- Knowledge of appropriate therapeutic area indications preferred
- Appropriate tertiary qualification in health-related disciplines (Medical, Scientific, Nursing) preferred
- Strong cross-functional collaboration skills
- Strong planning and organizational skills
- Ability to work effectively in a dynamic environment with competing projects and deadlines
- Advanced ability to leverage technology, tools, and resources
- Strong interpersonal, written, verbal, active listening, and presentation skills
- Ability to establish and leverage site relationships and trusted partnerships
- Ability to apply critical thinking and good judgment to address clinical site issues
- Self-motivated and focused on timely, quality outcomes
- Acts with integrity in accordance with AbbVie code of business conduct and leadership values
Benefits
Comp & perks- Paid time off (vacation, holidays, sick)
- Medical, dental, and vision insurance
- 401(k)
- Short-term incentive programs
- Equal opportunity employer
- Reasonable accommodation for US & Puerto Rico applicants