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Clinical Study Coordinator II

2 months ago

Carson City, Nevada, United States Ascendion Inc. Full time
About the Role

As a Clinical Study Administrator II at Ascendion Inc., you will play a vital role in supporting the clinical study staff within our Clinical R&D COE. Your primary responsibility will be to provide administrative support to project managers and clinical study staff, ensuring the timely tracking of study essential documents and maintaining the completeness of the Trial Master File.

Key Responsibilities
  • Process, track, and file study documents, and manage the Trial Master File within clinical projects.
  • Administer support to clinical study staff as required, including providing internal communication of important clinical data and events.
  • Assist study staff and investigators to resolve issues relating to Study Files (Trial Master File and Investigator Site File).
  • Respond to problems and assist in implementing corrective and preventive actions.
  • Support ongoing use of CTMS by maintaining and tracking relevant activities.
  • Provide safety documentation to other functional groups in support of safety committee meetings as requested.
Additional Administrative Tasks
  • May be asked to provide support for study supplies creation, ordering, and distribution to sites.
  • May be asked to assist with device tracking and ordering if required and applicable.
  • Assistance with logistics for Investigator meetings and expert panel meetings.
  • Assistance with distribution of newsletters (create mailing list from CTMS and routing for internal approval).
  • Participates in process improvement activities related to CTMS/v-TMF within the department.
Position Information

This position is eligible for commissions in accordance with the terms of the Company's plan. Commissions for this position are estimated to be based on individual performance. Additionally, this role is also eligible for a bonus based on the achievement of mutually agreed KRAs.