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AbbVie
AbbVie
H1B Visa SponsorConsultingHealthcareManufacturing
AbbVie is a global pharmaceutical company focused on discovering, developing, and delivering medicines for complex health conditions. Its portfolio spans immunology, oncology, neuroscience, and aesthetics, with operations serving patients in more than 175 countries. The company’s work combines pharmaceutical research, manufacturing, and healthcare expertise, supported by substantial investment in scientific innovation and research and development. AbbVie also highlights diversity, sustainability, and patient support as part of its broader approach to improving health outcomes and community impact.
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Senior Clinical Research Associate (Remote, Hungary)

AbbVie is hiring a Senior Clinical Research Associate to oversee clinical trial sites in Hungary. The role focuses on site monitoring, regulatory compliance, audit readiness, study execution, and CRA development.

HUHungaryRemoteFull-timeSeniorEnglish RequiredClinical Research
Google Cloud Platform

Description

  • Deliver protocol-level SMM activities for assigned sites and studies throughout start-up, execution, and close-out.
  • Conduct monitoring visits, site evaluations, selection and activation activities, close-out visits, and monitoring reports.
  • Identify and resolve site issues that could affect study timelines.
  • Keep clinical trial management systems updated with accurate site-level information.
  • Apply expertise in local regulatory and legal requirements.
  • Coordinate timely payments for assigned sites and studies.
  • Ensure compliance with regulations, GCP, ICH Guidelines, SOPs, Monitoring Plans, and quality standards.
  • Monitor changes to local regulations, guidelines, and policies.
  • Maintain audit and inspection readiness and advise on pre-audit GCP activities.
  • Prepare for and follow up on site audits and inspections, contributing to CAPA development.
  • Coach and mentor CRAs while supporting their professional development.
  • Act as the country contact for CROs when assigned.
  • Contribute to or lead global and local task forces and initiatives.
  • Identify training needs and help standardize and deliver training for SMM monitors when assigned.
  • Support onboarding and incorporate lessons learned into monitoring materials and best-practice curricula when assigned.
  • Serve as a country or district study contact when assigned.
  • Update Impact/Tesla with country planning data and LSR assignments when assigned.
  • Represent assigned studies globally when required.
  • Perform remote data reviews in line with the IDRP, Monitoring Plan, SOP/WI, timelines, and study objectives when assigned.
  • Provide regular feedback on investigator and site performance.
  • Build effective, collaborative relationships with peers and site monitors.

Requirements

  • Bachelor’s degree or equivalent in a health-related discipline, such as medicine, science, nursing, or pharmacy, is preferred.
  • At least three years of site monitoring experience.
  • Strong analytical and critical-thinking abilities.
  • Excellent interpersonal and persuasive communication skills.
  • Adaptability and flexibility when requirements change.
  • Resourceful, creative approach to problem-solving.
  • Proactive, positive, and collaborative team orientation.
  • Strong planning and organizational capabilities.
  • Ability to manage competing projects and deadlines in a dynamic environment.
  • Consistent commitment to business ethics and integrity.
  • Working knowledge of federal and applicable local regulations, GCP, ICH Guidelines, AbbVie SOPs, Monitoring Plans, and quality standards.
  • Knowledge of local regulatory and legal requirements.
  • Ability to maintain audit and inspection readiness.

Benefits

  • Option to work remotely.
  • Equal opportunity employer.
  • Work environment centered on integrity, innovation, improving lives, and community service.

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