Assistant CRA

• 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.

• 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 for relevant site staff during pre-activation and subsequent course of the study.

• Provides support to follow-up on site staff training, as applicable.

• Coordinates and supports logistics for IM attendance, as directed.

• Supports maintenance of vendor trackers, as directed.

• Coordinates study/site supply management during pre-activation and subsequent course of the study.

• Supports Essential Document collection, review and updating in systems, as applicable.

• Follows up and supports on missing study vendor data like ECGs, lab samples, 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.

• Verifies document collection status in CRG systems and drives action for missing/incomplete/expired documents and open document findings, as directed.

• May perform other assigned site management tasks, as directed by RCRA and as per Task Matrix.

• May perform a specific role profile for FSP opportunities according to Client requests.

• Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner.