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.