Study Startup Coordinator

at

PSI CRO

Remote, REMOTE
Full Time
17 days ago

Company Description

We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do.  A dynamic, global company founded in 1995, we bring together more than 2,300 driven, dedicated and passionate individuals.  We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.

Job Description

  • Monitors startup key performance indicators for selected projects on regional/country level
  • Identifies and escalates operational issues to Project Management and other functions concerned
  • Cooperates with other functions to conduct training and work on process improvement pertaining to study and site startup
  • Partakes in the development and update of local instructions and guidelines related to startup activities
  • Provides startup support for selected projects - starting from handover to Operations until all sites are activated
  • Participates in regional kick-off meetings/calls
  • Provides support and technical assistance in feasibility and site identification process
  • Coordinates and supports contract negotiation process 
  • Coordinates and supports preparation of IP-RED packages
  • Performs training of team members tailored to project needs

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 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

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. You will lead dedicated startup teams and work closely with cross-functional experts to drive your startup projects forward.

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