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.
Remote Clinical Research Associate II, Oncology at AbbVie
Support AbbVie’s oncology clinical trials through site monitoring, investigator collaboration, and risk management. Help maintain data integrity, recruitment, compliance, and patient safety across trial activities.
Descriere
- Advance AbbVie’s clinical development pipeline through high-quality clinical research
- Act as the primary contact for investigative sites
- Provide clinical trial context and connect internal stakeholders with investigative sites
- Align, train, and motivate site staff and principal investigators on trial objectives, protocols, and patient treatment principles
- Perform site evaluation, training, routine monitoring, and closeout activities
- Maintain compliance with protocols, monitoring plans, regulations, GCPs, ICH Guidelines, SOPs, and quality standards
- Create and tailor strategies for engaging investigative sites
- Collect site insights and use CRM tools to monitor progress and assess impact
- Support trial execution by translating protocols and scientific principles into daily activities
- Assess recruitment and retention approaches in relation to the patient disease journey
- Build knowledge of therapeutic areas, assets, the clinical landscape, and patient journeys
- Mentor and train junior CRAs and contribute development feedback
- Contribute to global and local task forces and initiatives
- Perform ongoing risk assessments with the Central Monitoring team
- Address site risk signals and implement preventive and corrective action plans
- Identify and assess prospective investigators and investigative sites
- Protect data quality, timely data submission, safety-event reporting, and required follow-up
- Maintain readiness for audits and regulatory inspections
- Administer investigator payments in line with executed contract obligations, where applicable
Cerințe
- At least one year of clinically related experience
- At least six months of clinical research monitoring experience in investigational drug or device trials
- Familiarity with risk-based monitoring, including onsite and offsite monitoring
- Knowledge of relevant therapeutic-area indications is preferred
- Advanced knowledge of local regulatory and legal requirements, ICH/GCP Guidelines, and applicable policies
- Strong ability to collaborate across functions
- Strong planning and organizational capabilities
- Ability to work effectively in a dynamic environment with competing projects and deadlines
- Ability to use technology, tools, and available resources effectively
- Strong interpersonal, written, verbal, active-listening, and presentation skills
- Ability to build site relationships and trusted partnerships
- Critical-thinking skills and sound judgment when addressing clinical site issues
- Integrity aligned with AbbVie’s code of business conduct and leadership values
- Self-motivated approach with focus on timely, high-quality outcomes
- A relevant tertiary qualification in a health-related field such as medical, scientific, or nursing is preferred
Beneficii
- Paid vacation, holiday, and sick leave
- Medical, dental, and vision insurance
- 401(k) retirement plan
- Eligibility for short-term incentive programs
- Equal opportunity employer
- Reasonable accommodation is available for applicants in the United States and Puerto Rico