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Clinical Trial Administrator

3 months ago

King of Prussia, United States PSI CRO Full time

Job Description

Is your CV ready If so, and you are confident this is the role for you, make sure to apply asap.

Hybrid role in King of Prussia, PA

Study Administration

Ensures that the project team is timely supplied with study information and documents.  

Coordinates information flow on clinical supplies inventory, storage, and reconciliation within the project team.

Supports the project team with regulatory and ethics committee submissions and notifications.

Administers financial tasks within the project team.

Supports preparation for and follow-up on site, TMF and systems audits and inspections.  

Other Communication

Exchanges information and documentation with other PSI departments.

Supports organization of internal team meetings, including preparation of agenda and minutes.

Supports organization of Investigator Meetings.

Ensures completeness and consistency of information in study-specific and corporate tracking systems.

Training

Tracks initial and ongoing training of Monitors and Site Management Associates.

Ensures appropriate access is provided to new project team members and changed/revoked for those who change their status in the project team.

 Provides administrative support and coaching in the project team for new project team members. 

Document Management

 Maintains and performs periodic checks of the Trial Master File (TMF) on a site and country level.

Files study-related documents in the TMF.

Assists with translations of study-specific documents.

Performs translation review of all non-patient facing study documents.

Circulates all new and updated study- and country-related documents of administrative nature in the project team.

Safety Management

Assists with safety information flow with the investigative sites.

CTMS Management

Updates CTMS with all administrative information.

Cooperates with the Monitor to make sure all administrative tracking records are timely completed by the Monitor in CTMS.

Ensures all project team members have proper access to CTMS.