Clinical Research Associate II
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Job Description
Clinical Research Associate II advancing AbbVie’s innovative medicines through immunology trials. Managing investigative sites, monitoring compliance, data integrity, recruitment and patient safety.
Responsibilities:
- Advance AbbVie’s clinical pipeline through excellence in clinical research and advanced capabilities
- Serve as the primary point of contact for the investigative site
- Provide contextual information on clinical trials and connect stakeholders with investigative sites
- Align, train and motivate site staff and principal investigators on trial goals, protocol 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, AbbVie SOPs and quality standards
- Develop and customize site engagement strategies for assigned studies
- Gather local and site insights; use CRM tools to track progress and measure impact
- Connect study protocols, scientific principles and clinical trial requirements to daily trial execution
- Evaluate and ensure effective patient recruitment and retention techniques/plans
- Develop therapeutic-area, asset, clinical-landscape and patient-journey knowledge
- Mentor and train less experienced CRAs and contribute to their development
- Participate in global/local task forces and initiatives
- 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 potential investigators and sites
- Ensure quality and timely submission of site data, 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
- Perform additional activities assigned by the manager
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 of investigational drug or device trials required
- Familiarity with risk-based monitoring approach, onsite and offsite monitoring
- Knowledge of appropriate therapeutic area indications preferred
- Ability to understand and apply scientific concepts to clinical trial conduct
- 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 for customer-centric site 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
- 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 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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