Clinical Research Associate II
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Job Description
Clinical Research Associate II advancing AbbVie’s innovative medicines through clinical trial site management. Monitoring sites, ensuring compliance, data integrity, recruitment, and patient safety.
Responsibilities:
- 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 activities
- Ensure compliance with protocols, monitoring plans, applicable regulations, GCPs, ICH Guidelines, SOPs, and quality standards
- Develop and customize site engagement strategies for assigned studies
- Gather local and site insights and use CRM tools to track progress and measure impact
- Support clinical trial execution by connecting protocols, scientific principles, and trial requirements to daily activities
- Evaluate recruitment and retention techniques based on the patient disease journey
- Develop therapeutic-area, asset, clinical-landscape, and patient-journey knowledge to support recruitment and protocol compliance
- Mentor and train less experienced CRAs and provide development input
- Participate in global or local task forces and initiatives
- Conduct continuous risk assessment with the Central Monitoring team to identify study-performance and patient-safety issues
- Resolve site risk signals and implement preventative and corrective action plans
- Identify, evaluate, and recommend investigators and sites
- Ensure timely, accurate site data submission and appropriate safety-event reporting and follow-up
- Maintain audit and regulatory inspection readiness
- Manage investigator payments according to executed contract obligations, as applicable
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 approaches, including 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
- 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
- Integrity in accordance with AbbVie’s code of business conduct and leadership values
- Self-motivated and focused on timely, quality outcomes
Benefits:
- Paid time off (vacation, holidays, sick)
- Medical, dental, and vision insurance
- 401(k)
- Short-term incentive program eligibility
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