Clinical Trial Coord

8 months ago

Melbourne, Australia Thermo Fisher Scientific Full time

Provides administrative and technical support to the Project Team. Supports audit readiness by ensuring files are reviewed according to the schedule detailed in the organization's SOP and department guidance document. Provides administrative support for site activation activities. Aids the development of the critical path for site activation within assigned projects in support of rapid site activations. Represents CRG personnel. May utilize local knowledge, organization systems, external site lists and sponsor directives to develop and review site lists that are suitable for the strategic needs of feasibility activities and to provide local input into the site tiering process. May act as a buddy during onboarding phase and provide training to new staff as needed.

Essential Functions

According to the specific role (Central or Local), coordinates, oversees and completes functions on assigned trial(s) activities as detailed on the task matrix.

Performs department, Internal, Country and Investigator file reviews as assigned, and documents findings in appropriate system(s).

Ensures allocated tasks are performed on time, within budget and to a high-quality standard. Proactively communicates any risks to project leads.

Provides system support (i.e., Activate & eTMF) and ensures system databases are always current. Performs administrative tasks on assigned trials, including, but not limited to, timely processing of documents sent to Client (e)TMF as assigned, performing (e)TMF reviews, distributing mass mailings and communications as needed, providing documents and reports to internal team members. Analyzes and reconciles study metrics and findings reports. Assists with clarification and resolution of findings related to site documentation.

Assists with coordination, compilation and distribution of Investigator Site File (ISF) and Pharmacy binder materials and non-clinical study supplies to sites.

Assists with study-specific translation materials and translation QC upon request.

Maintains knowledge of and understands SOPs, client SOPs/directives, and current regulatory guidelines as applicable to services provided. Where applicable, conducts on-site feasibility visits (Asia Pac only).

May support scheduling of client and/or internal meetings.

May review and track of local regulatory documents.

May provide system support (i.e., Activate & eTMF). May support RBM activities.

May support the maintenance of study specific documentation and systems, including, but not limited to, study team lists, tracking of project specific training requirements, system access management and tracking of project level activity plans in appropriate system(s).

Transmits documents to client and centralized IRB/IEC.

Maintains vendor trackers.

Supports start-up team in Regulatory submissions. Works directly with sites to obtain documents related to site selection.

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