Clinical Research Associate II – Immunology
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Job Description
Clinical Research Associate monitoring immunology clinical trials for AbbVie, an innovative medicines company. Ensuring site compliance, data integrity, patient safety, and recruitment performance.
Responsibilities:
- 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)
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