Clinical Research Associate II
2 weeks ago
The primary goal of this position is to ensure the successful execution of clinical studies at AbbVie. This involves proactively identifying and resolving study-related issues at clinical sites, ensuring compliance with regulatory requirements, and maintaining high-quality data submission.
Responsibilities- Monitor clinical site activities to ensure adherence to federal regulations, Good Clinical Practices (GCPs), and AbbVie Standard Operating Procedures (SOPs).
- Conduct site qualification, initiation, interim monitoring, and study closeout visits for Phase 1-4 studies.
- Oversee site personnel and motivate them to meet study objectives, ensuring regulatory inspection readiness.
- Ensure data quality and timely submission, including reporting and follow-up for safety events.
- Protect study subjects by ensuring compliance with the study monitoring plan, AbbVie SOPs, and applicable regulations.
- Train site personnel on protocols and regulatory requirements.
- Manage investigator payments and negotiate agreements with stakeholders.
- Identify and recommend new investigators/sites for clinical studies.
- Appropriate tertiary qualification in a health-related field (e.g., Medical, Scientific, Nursing) is preferred.
- Minimum 1 year of clinically-related experience, with 6 months in clinical research monitoring.
- Current knowledge of therapeutic indications and regulations governing clinical research.
- Strong planning, organizational, and analytical skills, with excellent communication and interpersonal abilities.
- Demonstrated business ethics and integrity.
AbbVie is an equal opportunity employer committed to operating with integrity, driving innovation, and transforming lives. We value diversity and inclusion and are dedicated to creating a workplace where everyone feels valued and respected.
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