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Clinical Research Associate I – Oncology
Job Description:
- Advance AbbVie’s clinical research pipeline and support the development of innovative medicines
- Serve as the primary point of contact for investigative sites
- Provide clinical trial information 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, training, routine monitoring, and site closure activities under supervision
- Ensure compliance with protocols, monitoring plans, regulations, GCPs, ICH Guidelines, AbbVie SOPs, and quality standards
- Customize site engagement strategies and track progress using CRM tools
- Connect study protocols, scientific principles, and clinical trial requirements to day-to-day execution
- Evaluate and support patient recruitment and retention plans
- Develop therapeutic-area, asset, clinical-landscape, and patient-journey knowledge
- Conduct continuous risk assessments with the Central Monitoring team
- Resolve site risk signals and implement preventative and corrective action plans
- Identify, evaluate, and recommend investigators and clinical sites under supervision
- Ensure data quality and timely submission, including safety-event reporting and follow-up
- Maintain audit and regulatory inspection readiness
- Manage investigator payments according to executed contracts, as applicable
Requirements:
- Appropriate tertiary qualification in health-related disciplines (Medical, Scientific, Nursing) preferred, or experience or equivalent work experience
- Clinically related experience, preferably in clinical research coordinating or data management
- Knowledge of appropriate therapeutic area indications preferred
- Ability to understand and apply scientific concepts to clinical trial conduct
- Knowledge of local regulatory and legal requirements, ICH/GCP Guidelines, and applicable policies
- Ability to work collaboratively and cross-functionally
- Planning and organizational skills; ability to work effectively in a dynamic environment with competing projects and deadlines
- Ability to leverage technology, tools, and resources
- Critical thinking and good judgment to address clinical site issues
- Strong written, verbal, active listening, and presentation skills
- Ability to establish and leverage site relationships and trusted partnerships
- 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:
- Paid time off (vacation, holidays, sick)
- Medical, dental, and vision insurance
- 401(k)
- Short-term incentive program eligibility
- Equal opportunity employment
- Reasonable accommodations for applicants with disabilities
