Assistant CRA
Thermo Fisher Scientific
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
Essential Functions
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 Assessment waivers, as agreed for project. Performs remote review of EMR/EHR checklist and supports collection, as applicable assessments. Supports site staff with the vendor related qualification process, where applicable. Provides support by ensuring system access is requested/granted and revoked Provides support to follow-up on site staff training, support logistics for IM as appplicable. Coordinates study/site supply management during pre-activation and subsequent course of the study. Follows up and supports on missing study vendor data like ECGs, lab amples, 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. May perform other assigned site management tasks, as directed by RCRA and as per Task Matrix. Maintains & completes administrative tasks such as expense reports andtimesheets in a timely manner
Education and Experience:
Bachelor's degree or equivalent and relevant formal academic / vocational qualification Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 2 years).
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