Assistant CRA
Detail posisi
Kewajiban
• Completes study and site management activities as defined in task matrix, and as applicable and directed for study assigned.
• Completes and documents study-specific training.
• Orients and trains on any company/study-specific systems.
• Provides in-house support during pre-study assessments and with pre-study assessment waivers, as agreed for project.
• Supports to customize Site ICF with site contact details, as needed.
• Performs remote review of EMR/EHR checklist and supports collection, as applicable assessments.
• Verifies document collection and RCR submission status; updates site EDL and verifies site information.
• Reviews patient facing materials and review translations, as directed.
• Supports site staff with the vendor related qualification process, where applicable.
• Provides support by ensuring system access is requested/granted and revoked.
Kualifikasi
• Knowledge of clinical research processes and regulations.
• Strong organizational and communication skills.
• Ability to work independently and as part of a team.
• Proficiency in using clinical trial management systems and other relevant software.
• Attention to detail and commitment to quality.