„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
Support AbbVie’s immunology clinical trials by monitoring research sites and safeguarding compliance, data integrity, patient safety, and recruitment.
Aprašymas
- 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.
Reikalavimai
- 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.
Privalumai
- Equal opportunity employer.
- Commitment to integrity, innovation, improving lives, and community service.
- Remote work available.