Clinical Study Administrator

Responsibilities

• Work with Study Teams and partners to maintain and track relevant activities in CTMS.
• Create and distribute regulatory binders.
• Track study essential documents in a timely manner and ensure completeness of the Trial Master File for assigned clinical studies according to appropriate regulations, departmental guidelines, and work instructions.
• Distribute safety documentation to other functional groups in support of safety committee meetings as requested (supporting role).
• Create and generate system reports.
• Provide support for study supplies creation, ordering, and distribution to sites (e.g., print protocols, burn DVDs).
• Assist with device tracking and ordering if required and applicable.

Requirements

• Minimum of a Bachelor’s Degree is preferred.
• Experience with Veeva as CTMS and TMF.
• Previous clinical research experience is a plus.
• Requires previous administrative support experience or equivalent for at least 1 year.
• Clinical/medical background is a plus.
• Experience and knowledge working with computer systems (Microsoft Office—Excel, Word, and PowerPoint).