Project Support Coordinator

Accountabilities have an immediate opening for a Project Support Coordinator to support pharmaceutical company in Groton, CT.

Job Description:

· Primary point of contact for the study team after the protocol has ‘gone live’.

· Interact with study team after protocol ‘go-live’ date to address any study specific issues that should arise.

· Responsible for monitoring the data in Impala and reporting any issues or trends to the team coordinators or project team as appropriate; this may include but is not limited to the following: reviewing drug supply, shipments, inventory, subject visits and enrollment.

· Ensure the completion of the container file data load requirement within Impala according to the PLA and parameters on the variable worksheet; ensure center importation.

· Participate in the QC Process as required when assigned new protocols.

· Implement data load changes within the Protocol Administration System as requested by the clinical team; this may require turning the protocol off and the addition/removal of certain parameters.

· Review and release shipments on a daily basis to ensure ‘just in time’ delivery of study medication to investigator sites; this may include manual review of shipments for protocols that are experiencing limited drug supply.

· Facilitate/attend training sessions to provide training to various user groups as needed

· Provide 24x7 support for IVRS and manage issue resolution with efficient response time according to the PAG on-call schedule.

· Provide helpdesk phone support to investigator sites during normal business hours on a daily basis and create corresponding tickets in data tracking tool

· Monitor IVRS issues and their resolution, utilizing the current PAG tracking procedures and Knowledge Base.

· Responsible for conceptual and practical understanding and execution of issue escalation procedures (language line, CIT, EDC Call Tree).

· Responsible for participating and contributing to the PAG Workshops