Clinical Trial Coord

3 weeks ago

Mumbai Maharashtra, India Thermo Fisher Scientific Full time

Coordinates, oversees and completes functions on assigned trials activities detailed on the task matrix.
- Performs department, Internal, Country and Investigator file reviews as assigned and documents findings in appropriate system.
- Ensures allocated tasks are performed on time, within budget and to a high quality standard. Proactively communicates any risks to project leads and line manager as appropriate.
- Supports the maintenance of study specific documentation and global support with specific systems, tools and trackers including but not limited to: study team lists, tracking of project specific training requirements, system access management for organization/vendor/clients, and tracking of project level activity plans in appropriate system. Ensures (e)TMF is up to date by following file review schedules and documents findings in appropriate system.
- Provides system support (i.e. GoBalto & eTMF).
- Supports RBM activities.
- 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, performing mass mailings and communications as needed, providing documents and reports to internal team members.
- Supports scheduling and organization of client and/or internal meetings with completion of related meeting minutes.
- Reviews and supervises local regulatory documents.
- Transmits documents to client and centralized IRB/IEC.

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