Clinical Research Associate II
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Job Description
Clinical Research Associate advancing AbbVie’s innovative medicines through clinical site monitoring. Supporting investigators, protocol compliance, patient safety, data integrity, and recruitment.
Responsibilities:
- Advance AbbVie's clinical research pipeline and turn science into medicine
- 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, regulations, GCPs, ICH Guidelines, SOPs, and quality standards
- Customize site engagement strategies and track their progress using CRM tools
- 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/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 and recommend investigators and sites for clinical studies
- Ensure data quality and timely submission, including safety-event reporting and follow-up
- Maintain audit and regulatory inspection readiness
- Manage investigator payments as applicable
Requirements:
- Appropriate tertiary qualification in health-related disciplines (Medical, Scientific, Nursing) preferred
- Minimum of 1 year of clinically related experience, including 6 months in clinical research monitoring of investigational drug or device trials
- Familiarity with risk-based monitoring approach, onsite and offsite monitoring
- Knowledge of appropriate 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 site support
- Excellent 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
- Acts with integrity in accordance with AbbVie 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 programs
- Travel: 75% of the time
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