Clinical Studies Operations Specialist

Description

Support the conduct of clinical studies related as per clinical project timelines. Act as a liaison person between Clinical Study sites and other internal departments. Maintain the clinical study related documentation ahead, during and after the completion of the clinical study; work collaboratively with the Clinical Study Scientist and Clinical Research Associate, in conjunction with the clinical sites.

This role is based in St Louis, MO and is not a remote position.

• Assist in study agreement preparation with legal and other functions along with the concerned authorities at the clinical study sites.
• Prepare templates for budget estimates and facilitates communication between internal and external partners during contract and budget phases of the clinical study project.
• Manage the clinical sites referencing, purchase orders, invoicing processes, regular accruals.
• Assist with supply purchasing and support clinical research associate with supply management
• Prepare the documentation package for the purpose of the submission to Independent Ethic Committee or Independent Review Board, as per respective expectations
• Report any clinical study related relevant information to competent authorities (EUDAMED, Sunshine act...)
• Monitor and report the progress of the above activities to the Clinical Scientist or Clinical Research Associate
• Own the above site administrative support process

• Prepare the on-site documentation as per Good Clinical Practices (Investigator Study File - ISF)
• Handle any study paperwork or electronic documentation generated during the progress of the clinical study
• Structure, prepare and regularly feed the electronic clinical trial master file, including all the study documentation and main project deliverables.
• Own the above clinical trial related documentation process

Position Requirements:

* Associate Degree required

* 1+ years of clinical trial experience

* Skills in administrative tools (Office 365 , Teams, Outlook, ...), WebApp

* Team spirit and collaborative work among peers and with department members

* Excellent sense of customer service

* Good sense of adaptation, great organizational, ability to prioritize, rigor, methodical approach