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ThermoFisher Scientific Assistant CRA in Remote, Argentina

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.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

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