Clinical Research Associate I

Posted 2ds ago

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Job Description

Clinical Research Associate advancing AbbVie’s innovative medicines through clinical-trial site monitoring. Supporting investigator sites, recruitment, compliance, data integrity, and patient safety across the US.

Responsibilities:

  • Serve as the primary point of contact for investigative sites and provide contextual information on clinical trials
  • Connect stakeholders with investigative sites and strengthen AbbVie’s positioning
  • 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 under supervision
  • Ensure compliance with protocols, monitoring plans, regulations, GCPs, ICH Guidelines, SOPs, and clinical research quality standards
  • Customize site engagement strategies and use CRM tools to track progress and measure impact
  • Connect study protocols, scientific principles, and clinical trial requirements to daily execution activities
  • Evaluate and support effective patient recruitment and retention plans
  • Develop therapeutic-area, asset, clinical-landscape, and patient-journey knowledge
  • Conduct continuous risk assessment with the Central Monitoring team to identify study performance and patient safety issues
  • Resolve site risk signals and implement preventative and corrective action plans
  • Identify, evaluate, and recommend investigators and clinical sites under supervision
  • 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, or equivalent work experience
  • Clinically related experience, preferably in clinical research coordinating or data management
  • Knowledge of 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 for a dynamic environment with competing projects and deadlines
  • Ability to leverage technology, tools, and resources for customer-centric site support
  • Ability to apply functional expertise, critical thinking, and good judgment to clinical-site issues
  • Strong written, verbal, active-listening, and presentation skills
  • Ability to establish and leverage site relationships through engagement, motivation, and training
  • Integrity consistent with AbbVie’s code of business conduct and leadership values
  • Self-motivated and focused on timely, quality outcomes
  • Willingness and ability to travel 75% of the time
  • Candidates from the Southwest, Southeast, and Northeast regions and near a major airport strongly preferred

Benefits:

  • Paid time off (vacation, holidays, sick)
  • Medical, dental, and vision insurance
  • 401(k)
  • Eligibility to participate in short-term incentive programs
  • Remote work
  • Equal opportunity employer
  • Reasonable accommodation for US & Puerto Rico applicants