Assistant CRA

Job Description

 Completes study and site management activities as defined in task matrix, andas 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-studyasssessment 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, asapplicable assessments. Verifies document collection and RCR submission status; updates site EDL andverifies site information. Reviews patient facing materials and review translations, as directed. Supports site staff with the vendor related qualification process, whereapplicable. Provides support by ensuring system access is requested/granted and revokedfor relevant site staff during pre-activation and subsequent course of the study. Provides support to follow-up on site staff training, as appplicable. 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 subsequentcourse of the study. Supports Essential Document collection, review and updating in systems, asapplicable. 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 functionaldepartments within organization and site. Supports system updates andreconciliations, as directed and follows-up on site invoices throughout the studyperiod. Performs reconciliation tasks on assigned trials including but not limited to CRFand query status, deviations, SAEs and safety reports, as applicable. Verifies document collection status in CRG systems and drives action formissing/incomplete/expired documents and open document findings, as directed.

May perform other assigned site management tasks, as directed by RCRA and asper Task Matrix. May perform a specific role profile for FSP opportunities according to Clientrequests. Maintains & completes administrative tasks such as expense reports andtimesheets in a timely manner.