Clinical Research Associate II
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Job Description
Clinical Research Associate II supporting AbbVie’s oncology clinical trials in China. Monitoring investigative sites, ensuring compliance, managing risk, and improving recruitment and data quality.
Responsibilities:
- Advance AbbVie’s clinical research pipeline by striving for excellence in clinical research and turning science into medicine
- Partner with investigators and site staff to support effective clinical-trial engagements
- Serve as the primary point of contact for investigative sites
- Provide contextual information on clinical trials and connect stakeholders to 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, AbbVie SOPs and quality standards
- Customize site-engagement strategies and use CRM tools to report and track progress and measure impact
- Gather local and site insights to improve recruitment, retention, data integrity, compliance, study performance and customer experience
- Evaluate recruitment and retention techniques based on the patient disease journey
- Develop knowledge of the therapeutic area, asset, clinical landscape and patient journey
- 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 detect study-performance or patient-safety issues
- Resolve site-risk signals and implement preventative and corrective action plans
- Identify, evaluate and recommend new investigators and sites
- Ensure quality and timely submission of site data, 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:
- 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 with 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 and efficiently in a dynamic environment with competing projects and deadlines
- Advanced ability to leverage technology, tools and resources
- 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 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 delivering timely and quality outcomes in a fast-paced environment
Benefits:
- Employees can work remotely
- Equal opportunity employer
- Commitment to operating with integrity, driving innovation, transforming lives and serving the community
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