Clinical Trial Coord

2 days ago

Bengaluru, India PPD Full time

Provides administrative and technical support to the Project Team. Supports audit readiness by ensuring files are reviewed on schedule detailed in the organization's WPD and department guidance document.
- According to the specific role (Central or Local), 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.
- Supports 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.
- 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 of client and/or internal meetings. Reviews and tracks local regulatory documents. Transmits documents to client and centralized IRB/IEC.
- Analyzes and reconciles study metrics and findings reports. Assists with clarification and resolution of findings related to site documentation. Maintains vendor trackers.
- 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.
- High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification.
- Bachelor's degree preferred.
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 1 year).

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