Clinical Research Associate II
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Job Description
Clinical Research Associate II monitoring Phase 1–4 clinical trials for AbbVie, a medicines and healthcare solutions company. Ensuring site compliance, data quality, safety reporting, and regulatory readiness.
Responsibilities:
- Proactively solve study-related clinical site issues and recommend corrective actions
- Monitor clinical investigative sites for protocol compliance and successful study execution
- Ensure adherence to regulations, ICH/GCP Guidelines, AbbVie SOPs, monitoring plans, and quality standards
- Conduct site qualification, initiation, interim monitoring, and closeout visits for Phase 1–4 studies
- Manage and influence site personnel without direct authority to meet study objectives
- Ensure regulatory inspection readiness at assigned clinical sites
- Ensure quality and timely submission of study data and safety event reporting
- Protect study subjects through compliance with monitoring plans, SOPs, guidelines, and regulations
- Train study site personnel on protocols and regulatory requirements
- Manage investigator payments and negotiate investigator/hospital agreements
- Complete expense reports according to applicable guidelines
- Identify, evaluate, and recommend new investigators and clinical research sites
Requirements:
- Bachelor’s degree in a scientific or related field
- Minimum of 1 year of clinically-related experience
- 6 months of clinical research monitoring experience preferred
- Experience in on-site monitoring of investigational drug or device trials required
- Fluent in English, both written and verbal
- In-depth knowledge of therapeutic indications relevant to clinical trials
- In-depth knowledge of clinical research regulations, ICH/GCP Guidelines, and applicable regulations
- Strong planning and organizational skills
- Ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines
- Ability to understand and follow work processes within the assigned function
- Strong analytical and conceptual capabilities
- Strong interpersonal and communication skills
- Ability to address clinical site issues and initiate and communicate corrective actions
- Ability to use functional expertise and exercise good judgment
- Demonstrated business ethics and integrity
Benefits:
- Remote work option
- Equal opportunity employment
- Reasonable accommodation for US & Puerto Rico applicants
- Veterans/Disabled employment protections
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