Assistant CRA

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.