Clinical Trial Administrator

5 days ago

Toronto, Canada PSI CRO Full time

**Company Description**
- PSI is a leading Contract Research Organization with more than 28 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications.

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.

**Qualifications**
College or university degree or an equivalent combination of education, training and experience that presents the required knowledge, skills and abilities is considered sufficient.

Equivalency is defined as a minimum of 2 years’ experience in corporate or academic environment where administrative experience and technical skills have been gained.
- Basic proficiency in MS Word.
- Basic proficiency in MS Excel.
- Basic proficiency in MS Outlook.
- Basic proficiency in MS Power Point.
- Knowledge (following proper training) of applicable software and project specific systems.
- Basic typing skills in English (min. 40 words per minute)

**Additional Information**
All your information will be kept confidential according to EEO guidelines.

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