Study Startup Coordinator

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.

Job Description

This is an office-based position in Toronto, ON, Canada. This position has a hybrid schedule that includes office-based and home-based days. 

• Provides startup support for selected projects to Study Startup Managers starting from handover to Operations until all sites are activated
• Participates in regional kick-off meetings/calls between local project team, Project Manager and/or designees and local representatives of Feasibility, Regulatory and Legal departments
• May participate in the organization of the sponsor kick off meetings and Investigator Meetings
• Provides support and technical assistance in feasibility and site identification process.
• Coordinates and/or performs all administrative activities including: documents collection/distribution, translation, filing, CTMS maintenance, minutes keeping, OSF preparation, trackers maintenance, etc. 
• Under supervision, coordinates ordering, tracking and distribution of initial study medication and clinical supplies to the sites (as applicable)
• Coordinates and supports preparation of initial submission dossiers to competent authorities, ethics committees, and/or site submission dossiers (as applicable)
• Coordinates and supports contract negotiation process and provides adequate tracking and follow-up
• Coordinates and supports preparation of IP-RED packages
• Performs training of team members tailored to the project needs, when required
• Monitors startup key performance indicators for a selected group of projects on a regional/country level
• Identifies and escalates operational issues
• Cooperates with other startup functions (Study Startup Manager Country/Region, Site Contract Coordinator Country/Region etc.), where applicable, in conducting trainings related to project and site startup
• Takes part in the developing and updating local instructions and guidelines related to startup activities
• May assist the Study Startup Manager Country/Region or designee with creating regional benchmarks for startup key performance indicators

Qualifications

• College or University degree or an equivalent combination of education and experience that provides the individual with the required knowledge, skills, and abilities
• Minimum 18 months industry experience in clinical research in an administrative role
• Excellent knowledge of FDA guidelines and ICH GCP
• Experience in study startup is preferred

Additional Information

If you feel it is time to make your skills and knowledge visible within a growing company with true focus on its people, then PSI is the right choice for you.