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 
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