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 I, Oncology — AbbVie (Remote, United States)
Support AbbVie oncology clinical trials through site monitoring, regulatory compliance, data-quality oversight, patient-safety reporting, and study execution across the United States.
Descriere
- Support AbbVie’s clinical research pipeline and the development of innovative medicines
- Act as the primary liaison for investigative sites
- Share clinical trial information and connect relevant stakeholders with investigative sites
- Train, align, and engage site staff and principal investigators on trial objectives, protocols, and patient-treatment principles
- Perform site evaluation, training, routine monitoring, and closeout activities under supervision
- Maintain compliance with protocols, monitoring plans, regulations, GCP, ICH Guidelines, AbbVie SOPs, and quality standards
- Tailor site-engagement approaches and monitor progress through CRM tools
- Apply study protocols, scientific concepts, and clinical-trial requirements to daily operations
- Assess and support patient recruitment and retention strategies
- Build knowledge of the therapeutic area, asset, clinical landscape, and patient journey
- Complete ongoing risk assessments with the Central Monitoring team
- Address site risk indicators and execute preventive and corrective action plans
- Identify, assess, and recommend investigators and clinical sites under supervision
- Maintain data quality and timely submissions, including safety-event reporting and follow-up
- Keep sites prepared for audits and regulatory inspections
- Administer investigator payments in line with executed contracts, where applicable
Cerințe
- Preferred tertiary qualification in a health-related field such as medicine, science, or nursing, or equivalent relevant experience
- Relevant clinical experience, ideally in clinical research coordination or data management
- Familiarity with indications in the relevant therapeutic area is preferred
- Ability to interpret and apply scientific concepts to clinical-trial execution
- Knowledge of local regulatory and legal requirements, ICH/GCP Guidelines, and applicable policies
- Collaborative approach with the ability to work across functions
- Strong planning and organizational abilities, with effectiveness in a changing environment and across competing deadlines
- Ability to use technology, tools, and available resources effectively
- Sound critical thinking and judgment when addressing clinical-site issues
- Strong written, verbal, active-listening, and presentation abilities
- Ability to build and use site relationships and trusted partnerships
- Commitment to integrity under AbbVie’s code of business conduct and leadership values
- Self-directed, quality-focused approach with the ability to deliver on time in a fast-paced setting
Beneficii
- Paid vacation, holiday, and sick leave
- Medical, dental, and vision coverage
- 401(k) plan
- Eligibility for a short-term incentive program
- Equal opportunity employment
- Reasonable accommodations for applicants with disabilities