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.