Purpose
- Advance AbbVieโs pipeline by striving for excellence in clinical research, turning science into medicine for patients, and leveraging advanced capabilities to drive industry-leading performance.
- Partner with investigators and site staff for meaningful engagements that position AbbVie as the choice in clinical trials.
- Focus on site clinical research to ensure appropriate trial conduct while improving data integrity, compliance, overall study performance, and customer experience.
Responsibilities
- Primary point of contact for the investigative site; provide contextual trial information and strengthen AbbVieโs positioning.
- Align, train, and motivate site staff and principal investigator on trial goals, protocol, and patient treatment principles.
- Conduct site evaluation, training, routine, and closure monitoring in compliance with protocol, monitoring plans, regulations, GCPs, ICH guidelines, AbbVie SOPs, and quality standards.
- Customize site engagement strategy using local/site insights and tools (e.g., CRM) to track progress and measure impact.
- Connect study protocol/scientific principles to day-to-day execution; evaluate recruitment and retention plans across the patient disease journey.
- Mentor and train less experienced CRAs; may participate in task forces/initiatives as assigned.
- Perform proactive continuous risk assessment and collaborate with Central Monitoring to detect early performance or patient safety issues.
- Resolve site risk signals; ensure preventative/corrective actions to mitigate risk and promote compliance.
- Identify, evaluate, and recommend new investigators/sites.
- Ensure quality and timely submission of site data, safety reporting follow-up, audit/regulatory inspection readiness, and manage investigator payments as applicable.
Qualifications
- Preferred: tertiary qualification in health disciplines (Medical/Scientific/Nursing).
- Minimum 1 year clinically related experience; includes 6 months in clinical research monitoring of investigational drug/device trials; risk-based monitoring knowledge.
- Preferred: knowledge of therapeutic area indications and ability to apply scientific concepts to clinical trial conduct.
- Advanced knowledge of local regulatory/legal requirements, ICH/GCP, and applicable policies.
- Strong cross-functional collaboration, planning/organizational skills, technology leverage, interpersonal skills (written/verbal/presentation), and integrity; strong judgment/critical thinking.
Benefits
- Comprehensive benefits package including paid time off, medical/dental/vision insurance, and 401(k) (eligible employees).
- Eligible for short-term incentive programs.
Application Instructions
- Apply through AbbVie job posting; US & Puerto Rico applicants may request accommodations via the provided reasonable accommodation link.