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AbbVie
AbbVie
Sponsor pentru viza H1BAsistență medicalăConsultanțăIndustria prelucrătoare
AbbVie este o companie farmaceutică globală axată pe descoperirea, dezvoltarea și furnizarea de medicamente pentru afecțiuni complexe. Portofoliul său acoperă imunologia, oncologia, neuroștiința și medicina estetică, iar operațiunile sale deservesc pacienți din peste 175 de țări. Activitatea companiei combină cercetarea farmaceutică, producția și expertiza în domeniul sănătății, susținute de investiții substanțiale în inovarea științifică și cercetare și dezvoltare. AbbVie pune, de asemenea, accent pe diversitate, sustenabilitate și sprijinirea pacienților, ca parte a abordării sale mai ample pentru îmbunătățirea rezultatelor în domeniul sănătății și a impactului asupra comunităților.
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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.

HUUngariaRemoteNormă întreagăSeniorLimbă Obligatorie: englezăCercetare clinică
Google Cloud Platform

Descriere

  • 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.

Cerințe

  • 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.

Beneficii

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

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