Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
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 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 process 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.
