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
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