Clinical Research Associate II
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Job Description
Clinical Research Associate II advancing AbbVie’s oncology clinical trials in China. Monitoring investigative sites, ensuring data integrity, compliance, recruitment, and patient safety.
Responsibilities:
- Advance AbbVie’s clinical pipeline through excellence in clinical research
- Partner with investigators and site staff to support meaningful clinical-trial engagements
- 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 in compliance with protocols, monitoring plans, regulations, GCP, 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
- Evaluate recruitment and retention techniques based on the patient disease journey
- Build therapeutic-area, asset, clinical-landscape, and patient-journey knowledge to support recruitment and protocol compliance
- Mentor and train less experienced CRAs and contribute to their development
- Participate in global/local task forces and initiatives as assigned
- Conduct continuous risk assessment with the Central Monitoring team to identify study-performance or patient-safety issues
- Resolve site risk signals and implement preventative and corrective action plans
- Identify, evaluate, and recommend potential investigators and sites
- Ensure data quality and timely submission, including safety-event reporting and follow-up
- Maintain audit and regulatory inspection readiness at assigned sites
- Manage investigator payments according to executed contract obligations, as applicable
Requirements:
- 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 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 among internal and external stakeholders
- 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 for customer-centric site support
- Strong interpersonal skills with excellent written, verbal, active listening, and presentation skills
- Ability to establish and leverage site relationships and trusted partnerships through engagement, motivation, and training
- Ability to use functional expertise, 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 delivering timely, quality outcomes
- Appropriate tertiary qualification in a health-related discipline (Medical, Scientific, Nursing) preferred
Benefits:
- Employees can work remotely
- Equal opportunity employer
- Reasonable accommodation for US & Puerto Rico applicants
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