Clinical Research Associate II
Core
Monitor clinical investigative sites to ensure successful execution of Phase I-III study protocols, ensuring adherence to regulations and quality standards.
Role type
Senior Clinical Research Associate (Site Monitoring)
Builds
Clinical studies (Phase I-III) for AbbVie
Domain
Biopharmaceuticals / Clinical Research
Required skills
Clinical site monitoring, Protocol adherence, Regulatory compliance (GCP/ICH), Data quality assurance, Safety event reporting, Site qualification, Investigator management, Travel management
Preferred skills
Health-related tertiary qualification (Medical, Scientific, Nursing), Therapeutic area knowledge
Technologies
Microsoft Office Suite, Clinical trial systems
Responsibilities
Conduct site qualification, initiation, interim monitoring, and closeout visits; Ensure data quality and timely submission; Train site personnel on protocol and regulations; Manage investigator payments and agreements; Identify and evaluate potential investigators/sites; Ensure regulatory inspection readiness.
Seniority
Mid-level, hands-on IC