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Deschide
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’s immunology clinical trials through investigative-site monitoring, regulatory compliance, data-quality oversight, and patient-safety activities.
Descriere
- Advance AbbVie’s clinical research pipeline through high-quality research execution and effective use of available capabilities
- Collaborate with investigators and site teams to build productive clinical-trial relationships
- Act as the primary contact for investigative sites
- Share relevant trial information and connect stakeholders with investigative sites
- Train, align, and motivate site staff and principal investigators on trial objectives, protocols, and patient-treatment principles
- Perform site selection, initiation training, routine monitoring, and close-out monitoring in accordance with protocols, regulations, GCP, ICH guidelines, SOPs, and quality standards
- Tailor site-engagement plans, collect local insights, and use CRM tools to track progress and evaluate impact
- Translate study protocols, scientific concepts, and trial requirements into effective day-to-day execution
- Assess recruitment and retention approaches in the context of the patient disease journey
- Build knowledge of therapeutic areas, assets, the clinical landscape, and patient journeys to support recruitment and protocol adherence
- Coach less experienced CRAs and contribute to their development
- Contribute to global and local task forces and initiatives
- Work with the Central Monitoring team on ongoing risk assessments to identify study-performance and patient-safety concerns
- Address site-risk signals and execute preventive and corrective action plans
- Identify and assess prospective investigators and investigative sites
- Ensure site data is submitted accurately and on schedule, including safety-event reporting and follow-up
- Maintain readiness for audits and regulatory inspections
- Administer investigator payments when applicable
Cerințe
- A relevant tertiary qualification in a health-related field, such as medicine, science, or nursing, is preferred
- At least one year of clinically related experience, including six months monitoring investigational drug or device trials
- Experience with risk-based monitoring, including both onsite and remote monitoring
- Knowledge of the applicable therapeutic-area indications is preferred
- Advanced understanding of local regulatory and legal requirements, ICH/GCP guidelines, and relevant policies
- Ability to collaborate effectively with internal and external stakeholders across functions
- Strong planning and organizational abilities, with the capacity to manage competing projects and deadlines in a changing environment
- Advanced proficiency in using technology, tools, and resources to provide customer-focused site support
- Strong interpersonal, written, verbal, active-listening, and presentation skills
- Ability to build trusted site relationships through effective engagement, motivation, and training
- Sound critical-thinking and judgment skills for resolving clinical-site issues
- Commitment to integrity and compliance with AbbVie’s code of business conduct and leadership values
- Self-directed approach and consistent focus on timely, high-quality results in a fast-paced setting
Beneficii
- Equal-opportunity employer
- Commitment to integrity, innovation, transforming lives, and serving the community
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