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Clinical Research Associate II – Immunology

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Job Description:

  • Advance AbbVie’s clinical research pipeline and turn science into medicine for patients
  • Serve as the primary point of contact for investigative sites
  • Provide clinical trial context 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
  • Ensure compliance with protocols, monitoring plans, regulations, GCPs, ICH Guidelines, AbbVie SOPs, and quality standards
  • Develop and customize site engagement strategies
  • Gather site insights and use CRM tools to track progress and measure impact
  • Support clinical trial execution and protocol compliance
  • Evaluate recruitment and retention techniques based on the patient disease journey
  • Develop therapeutic-area, asset, clinical-landscape, and patient-journey knowledge
  • Mentor and train less experienced CRAs
  • Participate in global or local task forces and initiatives
  • Conduct continuous risk assessment with the Central Monitoring team
  • Monitor clinical sites for study-performance and patient-safety issues
  • Implement preventative and corrective action plans to mitigate risk and promote compliance
  • Identify, evaluate, and recommend investigators and sites
  • Ensure timely, accurate data submission and safety-event reporting
  • Maintain audit and regulatory inspection readiness
  • Manage investigator payments as required by executed contracts

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 for investigational drug or device trials
  • Familiarity with risk-based monitoring, onsite and offsite monitoring
  • Knowledge of applicable therapeutic area indications preferred
  • Advanced knowledge of local regulatory and legal requirements, ICH/GCP Guidelines, and applicable policies
  • Strong cross-functional collaboration skills
  • Strong planning and organizational skills
  • Ability to work effectively in a dynamic environment with competing projects and deadlines
  • Ability to leverage technology, tools, and resources for customer-centric 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
  • Critical thinking and good judgment to address clinical site issues
  • Ability to act with integrity in accordance with AbbVie’s code of business conduct and leadership values
  • Self-motivated approach focused on timely, quality outcomes in a fast-paced environment
  • Willingness and ability to travel 75% of the time

Benefits:

  • Paid time off, including vacation, holidays, and sick leave
  • Medical, dental, and vision insurance
  • 401(k)
  • Eligibility to participate in short-term incentive programs
  • Travel opportunities (role requires travel 75% of the time)
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