Clinical Research Associate II
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Job Description
Clinical Research Associate monitoring Phase I–III clinical trials for AbbVie, an innovative medicines company. Ensuring site compliance, data quality, subject safety, and regulatory readiness.
Responsibilities:
- Proactively solve study-related clinical site issues and initiate, recommend, and communicate corrective action
- Monitor clinical investigative site activities for successful protocol execution
- Ensure adherence to federal and local regulations, GCPs, ICH Guidelines, AbbVie SOPs, Monitoring Plans, and quality standards
- Conduct site qualification, initiation, interim monitoring, and study closeout visits for Phase I to III studies
- Oversee site personnel activities and motivate/influence them to meet study objectives
- Proactively manage sites and implement action plans to ensure compliance
- Ensure regulatory inspection readiness at assigned clinical sites
- Ensure quality and timely submission of study data, including safety event reporting and follow-up
- Ensure study subject safety and protection through compliance with monitoring plans, SOPs, guidelines, and regulations
- Train study site personnel on protocols and regulatory requirements
- Manage investigator payments according to executed contract obligations
- Negotiate investigator/hospital agreements with stakeholders
- Complete expense reports according to applicable guidelines
- Identify, evaluate, and recommend new or potential investigators and sites
Requirements:
- Appropriate tertiary qualification, health related (e.g., Medical, Scientific, Nursing) preferred
- Minimum of 2 years of clinically-related monitoring experience
- Experience in on-site monitoring of investigational drug or device trials is required
- Current in-depth knowledge and understanding of appropriate therapeutic indications as they relate to the conduct of clinical trials
- Current in-depth knowledge of regulations governing clinical research, ICH/GCP Guidelines and applicable regulations
- Familiarity with all aspects of study monitoring; data, drug accountability, documentation experience
- Strong planning and organizational skills and ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines
- Ability to work, understand and follow work processes within the assigned function
- Strong analytical and conceptual capabilities, interpersonal skills, and ability to communicate with clarity
- Ability to address study-related clinical site issues and initiate and communicate corrective action as indicated
- Ability to use functional expertise and exercise good judgment
- Demonstrated business ethics and integrity
- A minimum of 50% travel is required
- Proficient with Microsoft Office Suite (Outlook, PowerPoint, Excel, Word, etc.)
- Must be at ease with technology and various tools/systems used for day-to-day tasks
- Valid driver’s license and passport
Benefits:
- Innovative work culture
- Professional development
- Paid time off: vacation, holidays, personal days, and volunteer days
- Employee stock purchase
- Wellness spending account
- Flexible health insurance
- Retirement savings programs
- Bonus plan
- Remote work
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