AbbVie — күрделі денсаулық жағдайларына арналған дәрі-дәрмектерді ашуға, әзірлеуге және ұсынуға бағытталған жаһандық фармацевтикалық компания. Оның портфелі иммунология, онкология, неврология және эстетика салаларын қамтиды, ал қызметі 175-тен астам елдегі пациенттерге көрсетіледі. Компанияның жұмысы фармацевтикалық зерттеулерді, өндірісті және денсаулық сақтау саласындағы тәжірибені біріктіреді әрі ғылыми инновациялар мен зерттеулерге және әзірлемелерге қомақты инвестициялар арқылы қолдау табады. AbbVie денсаулық нәтижелері мен қоғамға әсерді жақсартуға бағытталған кең ауқымды тәсілінің бір бөлігі ретінде әртүрлілікті, тұрақты дамуды және пациенттерді қолдауды да атап көрсетеді.
Clinical Research Associate I, Neurology — California Remote
Support AbbVie’s neurology clinical trials by monitoring research sites and helping uphold regulatory compliance, data quality, patient safety, and recruitment goals.
Сипаттама
- Support AbbVie’s clinical research pipeline and promote high standards in trial delivery.
- Work with investigators and site teams to support effective clinical trial partnerships.
- Act as the main contact for investigative sites.
- Share clinical trial information and connect stakeholders with investigative sites.
- Guide, train, and motivate site staff and principal investigators under supervision.
- Carry out site assessments, training, routine monitoring, and closeout activities under supervision.
- Help ensure adherence to protocols, monitoring plans, regulations, GCP, ICH guidelines, SOPs, and quality standards.
- Tailor engagement plans for assigned study sites under supervision.
- Collect local and site insights, and use CRM tools to track progress and assess impact.
- Apply study protocols, scientific principles, and trial requirements to daily site work.
- Assess and support patient recruitment and retention plans.
- Build knowledge of the therapeutic area, study assets, clinical landscape, and patient journey.
- Continuously assess risk with the Central Monitoring team.
- Address site risk signals and clinical site issues.
- Put preventive and corrective actions in place to reduce risk and support compliance.
- Identify, assess, and recommend investigators and sites under supervision.
- Support accurate, timely submission of site data and safety event reports.
- Keep sites prepared for audits and regulatory inspections.
- Administer investigator payments in line with executed contract terms.
Талаптар
- A relevant tertiary qualification in a health discipline such as medicine, science, or nursing is preferred; equivalent work experience may also qualify.
- Clinically related experience, preferably in clinical research coordination or data management.
- Knowledge of indications in the relevant therapeutic area is preferred.
- Knowledge of local regulatory and legal requirements, ICH/GCP guidelines, and applicable policies.
- Ability to collaborate across teams and functions.
- Strong planning and organizational skills.
- Ability to work effectively in a changing environment with competing projects and deadlines.
- Ability to make effective use of technology, tools, and resources.
- Critical thinking and sound judgment.
- Strong written, verbal, listening, and presentation skills.
- Ability to build and maintain site relationships and trusted partnerships.
- Integrity and conduct aligned with AbbVie’s business code and leadership values.
- Self-motivation and focus on timely, high-quality results.
- Work authorization in the United States is implied by the US-based role and applicant provisions.
Артықшылықтар
- Paid leave, including vacation, holidays, and sick time.
- Medical, dental, and vision insurance.
- 401(k) plan.
- Short-term incentive programs.
- Equal opportunity employer.
- Reasonable accommodations for applicants.
- Employment practices inclusive of veterans and people with disabilities.