Job Description

Hybrid role in Research Triangle Park, NC

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.
• Maintains study-specific and corporate tracking systems
• Ensures communication between the sites and off-site facilities

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.

Vendor Management

• Ensures that pre-study testing (dummy scans, MRI/CT qualification questionnaires, test ECGs, etc.) of local site facilities is completed
• Tracks vendor-related supplies (lab kits, ECG electrodes, CDs for scans, etc.) on a site level

Additional responsibilities may include:

• Reviewing and coordinating site-specific query resolution
• Reviewing and coordinating site-specific EDC completion alongside site monitor
• Serving as a primary contact for sites for vendors, study supplies, and access management

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.