AbbVie
AbbVie
„AbbVie“ yra pasaulinė farmacijos bendrovė, daugiausia dėmesio skirianti sudėtingoms sveikatos būklėms gydyti skirtų vaistų atradimui, kūrimui ir tiekimui. Jos produktų portfelis apima imunologiją, onkologiją, neuromokslus ir estetiką, o bendrovė veikia daugiau nei 175 šalyse, aptarnaudama pacientus visame pasaulyje. Įmonės veikla apima farmacinius tyrimus, gamybą ir sveikatos priežiūros kompetenciją, kurią stiprina didelės investicijos į mokslines inovacijas bei mokslinius tyrimus ir plėtrą. „AbbVie“ taip pat pabrėžia įvairovę, tvarumą ir pacientų rėmimą kaip platesnio požiūrio į sveikatos rezultatų ir poveikio bendruomenėms gerinimą dalį.

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.

Aprašymas

  • 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

Reikalavimai

  • 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

Privalumai

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

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