Work Schedule

Environmental Conditions

Job Description

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 asssessment 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 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 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.