In the role of Study Startup Coordinator, you will act as a key coordination point for the wider team. Assisting with a range of duties including site identification, document management, contracts and budgets.
This is a home based position.
Your duties will include :
Monitoring startup key performance indicators for selected projects on regional / country level
Identifying and escalating operational issues to Project Management and other functions concerned
Cooperating with other functions to conduct training and work on process improvement pertaining to study and site startup
Partaking in the development and update of local instructions and guidelines related to startup activities
Providing startup support for selected projects - starting from handover to Operations until all sites are activated
Participating in regional kick-off meetings / calls
Providing support and technical assistance in feasibility and site identification process
Coordinating and supporting contract negotiation process
Coordinating and supporting preparation of IP-RED packages
Performing training of team members tailored to project needs
College or University degree or an equivalent combination of education and experience that provides the individual with the required knowledge, skills, and abilities
Minimum of 18 months industry experience in clinical research in an administrative role
Excellent knowledge of FDA guidelines and ICH GCP
Communication and interpersonal skills
Attention to detail
Ability to work in a team or independently
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.
We have a generous benefits package here at PSI as we understand the importance of giving back to our employees. Our benefits are focused on providing you with the support to excel both at work, and in your personal life!