The CRA II performs site qualification, site initiation, interim monitoring, site management, and close-out visits ensuring regulatory, ICH-GCP, and GPP compliance.
- Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits
- Ensures regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance
- Verifies the process of obtaining informed consent
- Assesses factors that might affect subject/patient’s safety and clinical data integrity
- Conducts Source Document Review of site source documents and medical records
- Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
- career development and progression
- supportive and engaged line management
- technical and therapeutic area training
- peer recognition
- total rewards program