Clinical Research Associate II - Neuro & Immunology (Remote US - Multiple Openings)
AbbVie
4 days ago
On-site
Chicago, IL
$84,500 - $162,000 USD yearly
Clinical Research and Development
We are hiring in Chicago, Southern California & NY (Northeast)
Responsibilities:
- Primary point of contact for the investigative site; provide clinical trial contextual information and strengthen AbbVie’s positioning.
- Align, train, and motivate site staff and the principal investigator on trial goals, protocol, and patient treatment principles.
- Conduct site evaluation, site training, routine monitoring, and site closure monitoring in compliance with protocol, monitoring plans, regulations, GCP/ICH guidelines, 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/retention based on patient journey; build knowledge of therapeutic area/asset/clinical landscape.
- Mentor/train less experienced CRAs; may participate in task forces; perform assigned activities.
- Proactively conduct risk assessment and collaborate with Central Monitoring to detect early performance or patient safety issues.
- Resolve site risk signals and ensure preventative/corrective actions to mitigate risk and promote compliance.
- Identify and recommend new investigators/sites; support placement of studies with qualified investigators.
- Ensure quality and timely submission of data, safety reporting follow-up, inspection readiness, and investigator payment management.
Qualifications:
- Preferred: tertiary qualification in Medical/Scientific/Nursing.
- Minimum 1 year clinically related experience; 6 months in clinical research monitoring of investigational drug/device trials; familiar with risk-based monitoring (onsite/offsite).
- Preferred: therapeutic area indication knowledge.
- Advanced knowledge of local regulatory/legal requirements, ICH/GCP, and applicable policies.
- Strong cross-functional collaboration; planning/organization; technology leverage.
- Excellent interpersonal, written/verbal, presentation skills; strong integrity and judgment.
Benefits (if eligible): Paid time off (vacation, holidays, sick), medical/dental/vision insurance, 401(k), and eligible for short-term incentive programs.
Responsibilities:
- Primary point of contact for the investigative site; provide clinical trial contextual information and strengthen AbbVie’s positioning.
- Align, train, and motivate site staff and the principal investigator on trial goals, protocol, and patient treatment principles.
- Conduct site evaluation, site training, routine monitoring, and site closure monitoring in compliance with protocol, monitoring plans, regulations, GCP/ICH guidelines, 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/retention based on patient journey; build knowledge of therapeutic area/asset/clinical landscape.
- Mentor/train less experienced CRAs; may participate in task forces; perform assigned activities.
- Proactively conduct risk assessment and collaborate with Central Monitoring to detect early performance or patient safety issues.
- Resolve site risk signals and ensure preventative/corrective actions to mitigate risk and promote compliance.
- Identify and recommend new investigators/sites; support placement of studies with qualified investigators.
- Ensure quality and timely submission of data, safety reporting follow-up, inspection readiness, and investigator payment management.
Qualifications:
- Preferred: tertiary qualification in Medical/Scientific/Nursing.
- Minimum 1 year clinically related experience; 6 months in clinical research monitoring of investigational drug/device trials; familiar with risk-based monitoring (onsite/offsite).
- Preferred: therapeutic area indication knowledge.
- Advanced knowledge of local regulatory/legal requirements, ICH/GCP, and applicable policies.
- Strong cross-functional collaboration; planning/organization; technology leverage.
- Excellent interpersonal, written/verbal, presentation skills; strong integrity and judgment.
Benefits (if eligible): Paid time off (vacation, holidays, sick), medical/dental/vision insurance, 401(k), and eligible for short-term incentive programs.