Purpose
- Advance AbbVieโs pipeline by striving for excellence in clinical research, turning science into medicine for patients, and leveraging advanced capabilities.
- Partner with investigators and site staff for meaningful, effective engagement in clinical trials.
- Focus on site clinical research to ensure appropriate trial conduct, improving data integrity, compliance, overall study performance, and customer experience.
Responsibilities
- Serve as the primary point of contact for investigative sites; provide contextual clinical trial information and strengthen AbbVieโs positioning.
- Align, train, and motivate site staff and principal investigators on trial goals, protocol, and patient treatment principles.
- Conduct site evaluation, training, routine monitoring, and site closure monitoring per protocol/monitoring plans, regulations, GCP, ICH, AbbVie SOPs, and quality standards.
- Customize site engagement strategy; gather local/site insights and use CRM tools to track progress and measure impact.
- Connect protocol/scientific principles to day-to-day execution; evaluate recruitment and retention plans based on patient journey.
- Mentor and train less experienced CRAs; may participate in task forces and initiatives.
- Proactively perform continuous risk assessment; collaborate with Central Monitoring to detect early performance/safety issues.
- Resolve site risk signals; ensure preventative/corrective actions to mitigate risk and promote compliance with a customer-centric approach.
- Identify and recommend new investigators/sites for ongoing study placement.
- Ensure quality and timely submission of data; support safety event reporting/follow-up; ensure audit/regulatory inspection readiness; manage investigator payments per contracts.
Qualifications
- Preferred: tertiary qualification in Medical/Scientific/Nursing.
- Minimum 1 year clinically related experience; includes 6 months in clinical research monitoring for investigational drug/device trials; familiar with risk-based monitoring and onsite/offsite monitoring.
- Preferred: therapeutic area knowledge; ability to apply scientific concepts to clinical trial conduct.
- Advanced knowledge of local regulatory/legal requirements and ICH/GCP.
- Strong cross-functional collaboration; planning/organization; technology/tool leverage for customer-centric support.
- Strong interpersonal, written/verbal, active listening, and presentation skills.
- Integrity per AbbVie code; self-motivated; delivers timely, quality outcomes in a fast-paced environment.