- Clinical research jobs
- Study Startup Coordinator
This job posting may have expired!
Use our `search` to find similar offers.
Use our `search` to find similar offers.
Similar jobs
Study Startup Coordinator
PSI CRO
Toronto , Canada
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.
Job posted: 2024-03-04