AbbVie
AbbVie
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.

Clinical Research Associate II – China (Remote)

Support AbbVie oncology trials in China by monitoring clinical sites, managing study risks and helping protect compliance, recruitment and data quality.

Descriere

  • Advance AbbVie’s clinical research by helping translate scientific work into medicine
  • Work with investigators and site teams to support effective clinical trial conduct
  • Act as the main contact for investigative sites
  • Explain trial context and connect stakeholders with investigative sites
  • Prepare, train and motivate site teams and principal investigators on trial objectives, protocols and patient care principles
  • Evaluate, train and monitor sites, including site closeout
  • Ensure adherence to protocols, monitoring plans, regulations, GCP, ICH guidelines, AbbVie procedures and quality standards
  • Tailor site engagement plans and use CRM tools to track progress and assess impact
  • Use local and site insights to strengthen recruitment, retention, data integrity, compliance, study performance and site experience
  • Assess recruitment and retention methods in light of the patient journey
  • Build knowledge of the therapeutic area, study asset, clinical landscape and patient journey
  • Coach and train junior CRAs and support their professional development
  • Contribute to global and local task forces and initiatives as assigned
  • Work with Central Monitoring on ongoing risk reviews to identify study performance or patient safety concerns
  • Address site risk signals and put preventive and corrective plans in place
  • Find, assess and recommend investigators and sites
  • Submit accurate site data on time, including safety event reports and follow-up
  • Keep assigned sites ready for audits and regulatory inspections
  • Oversee investigator payments where applicable, in line with signed contract terms

Cerințe

  • A relevant tertiary qualification in a health discipline such as medicine, science or nursing is preferred
  • At least one year of clinically related experience
  • At least six months of clinical research monitoring experience in investigational drug or device trials
  • Familiarity with risk-based monitoring, including onsite and offsite monitoring
  • Knowledge of relevant therapeutic area indications is preferred
  • Advanced knowledge of local regulatory and legal requirements, ICH/GCP guidelines and applicable policies
  • Strong collaboration skills with internal and external stakeholders across functions
  • Strong planning and organizational abilities
  • Ability to work efficiently in a changing environment with competing projects and deadlines
  • Advanced ability to use technology, tools and resources effectively
  • Strong interpersonal skills, including clear writing, speaking, active listening and presentation
  • Ability to build trusted site partnerships through engagement, motivation and training
  • Sound critical thinking and judgment when resolving clinical site issues
  • Integrity consistent with AbbVie’s code of business conduct and leadership values
  • Self-directed, with a focus on timely, high-quality work in a fast-paced environment

Beneficii

  • Remote work
  • Equal opportunity employer
  • Commitment to integrity, innovation, improving lives and community service

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