Assistant CRA

Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

Essential Functions

• 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 CRG/study-specific systems.
• Provides in-house support during pre-study assessments and with pre-study
• Assessment waivers, as agreed for project.
• Performs remote review of EMR/EHR checklist and supports collection, as
• applicable assessments.
• Supports site staff with the vendor related qualification process, where
• applicable.
• Provides support by ensuring system access is requested/granted and revoked
• Provides support to follow-up on site staff training, support logistics for IM as appplicable.
• Coordinates study/site supply management during pre-activation and subsequent course of the study.
• Follows up and supports on missing study vendor data like ECGs, lab amples, and e-diaries, as directed.
• Supports ongoing remote review of centralized monitoring tools, as directed.
• Supports Site payments processes by coordinating with various functional departments within organization and site. Supports system updates and reconciliations, as directed and follows-up on site invoices throughout the study period.
• Performs reconciliation tasks on assigned trials including but not limited to CRF and query status, deviations, SAEs and safety reports, as applicable.
• May perform other assigned site management tasks, as directed by RCRA and as per Task Matrix.
• Maintains & completes administrative tasks such as expense reports and

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• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 2 years).