AbbVie murakkab sog‘liq muammolari uchun dori vositalarini kashf etish, ishlab chiqish va yetkazib berishga e’tibor qaratadigan global farmatsevtika kompaniyasidir. Uning portfeli immunologiya, onkologiya, nevrologiya va estetika yo‘nalishlarini qamrab oladi, faoliyati esa 175 dan ortiq mamlakatdagi bemorlarga xizmat ko‘rsatadi. Kompaniya faoliyati farmatsevtika tadqiqotlari, ishlab chiqarish va sog‘liqni saqlash sohasidagi tajribani birlashtiradi hamda ilmiy innovatsiyalar va tadqiqotlar hamda ishlanmalarga kiritiladigan katta investitsiyalar bilan qo‘llab-quvvatlanadi. AbbVie sog‘liq natijalari va jamiyatga ta’sirni yaxshilashga qaratilgan kengroq yondashuvining bir qismi sifatida xilma-xillik, barqarorlik va bemorlarni qo‘llab-quvvatlashni ham ta’kidlaydi.
Clinical Research Associate II
Support AbbVie’s immunology clinical trials by monitoring research sites and safeguarding compliance, data integrity, patient safety, and recruitment.
Tavsif
- Contribute to AbbVie’s clinical development through high-quality research.
- Work with study teams, internal R&D partners, investigators, and site staff.
- Act as the sponsor’s main contact for investigative sites.
- Guide and train site staff and principal investigators on trial objectives, protocols, and patient care principles.
- Coach junior colleagues in site management.
- Evaluate and train sites, conduct routine on-site and remote monitoring, and complete closeout visits.
- Ensure trial conduct meets protocols, monitoring plans, regulations, GCP, ICH guidelines, AbbVie procedures, and quality standards.
- Tailor site engagement plans and measure their progress and effects.
- Use protocol, scientific, and clinical research expertise in day-to-day trial work.
- Create recruitment and retention approaches informed by patients’ disease journeys.
- Train and mentor less experienced CRAs and help onboard junior team members.
- Contribute to or lead local and global working groups and initiatives.
- Work with the Central Monitoring team on ongoing risk assessments.
- Find, assess, and recommend investigators and trial sites.
- Protect data quality, support timely submissions, and ensure safety events are reported and followed up appropriately.
- Keep records ready for audits and regulatory inspections.
- Oversee investigator payments where applicable, in line with signed contract terms.
Talablar
- A relevant tertiary qualification in health, such as medicine, science, pharmacy, or nursing, is preferred.
- At least three years of clinically related experience.
- Preferably two years of independent monitoring for investigational drug or device trials.
- Familiarity with risk-based monitoring and both on-site and remote monitoring.
- Knowledge of therapeutic indications and the ability to apply scientific concepts to clinical trial work.
- Knowledge of local regulatory and legal requirements, ICH/GCP guidelines, and applicable policies.
- Strong communication and cross-functional collaboration skills.
- Strong planning and organizational abilities.
- Ability to work effectively amid changing priorities, competing projects, and deadlines.
- Ability to use technology, tools, and resources to provide responsive site support.
- Strong interpersonal, written, verbal, listening, and presentation skills.
- Ability to build trusted site relationships through engagement, motivation, and training.
- Ability to resolve site issues independently using subject matter expertise, critical thinking, and sound judgment.
- Integrity aligned with AbbVie’s code of business conduct and leadership values.
- Self-directed approach and focus on timely, high-quality results in a fast-paced setting.
Imtiyozlar
- Equal opportunity employer.
- Commitment to integrity, innovation, improving lives, and community service.
- Remote work available.