Study Start Up Clinical Study Administrator

Responsibilities:

• Excellent employment opportunity for a Study Start Up Clinical Study Administrator (SSU CSA) in the Wilmington DE area.
• Location Remote (Must be able to work EST time/hours)
• SSU CSA is responsible for ensuring vendor spreadsheets are completed correctly and processed (submitted to vendor or global team) according to study team
  guidelines.
• Responsible for reviewing and processing all subInvestigator documents.
• SSU CSA will attend weekly Study Team meetings to report on vendor spreadsheets sub I document progression etc.
• All responsibilities are performed according to Company Procedural Documents International guidelines such as ICH and GCP as well as relevant local regulations.
• A SSU CSA with longer tenure and experience may take on additional responsibilities from the SSU Manager.
• Assist SSU Manager with obtaining and maintaining essential documents in compliance with ICHGCP Company Procedural Documents.
• Review and process start up documents including Sub Investigators documents in compliance with ICHGCP Company Procedural Documents
• Drive delivery of regulatory documents at the sites.
• Proactively identify delays in startup activities and the risks to the activation plan.
• Attend study team meetings and be prepared to provide a report on vendor spreadsheet status and sub I document status.
• Setup populate and accurately maintain information in Company tracking and communication tools (e.g. Veeva Clinical Box etc.) and support others in the usage of
  these systems

Experience:

• Strong verbal & written communication skills
• Strong organizational skills
• Previous Administrative experience
• Computer proficiency
• Level of education that supports Skills and Capabilities of the position and ensures successful conduct of accountabilities/responsibilities and appropriate interactions
  with internal/external customers completed High School and further studies in Administration.
• Experience with Vendor Management strong verbal & written communication skills and strong organizational skills
• Proven organizational and administrative skills
• Computer proficiency
• Very good knowledge of spoken and written English
• Display excellent organization and time management skills excellent attention to detail and ability to multitask in a highvolume environment with shifting priorities
• Team oriented and flexible; ability to respond quickly to shifting demands and nopportunities

Desirable Qualifications Skills and Experience

• Working knowledge of the Clinical Study Process and an understanding of the range of working procedures relating to study Startup together with an understanding of
  the ICH/GCP guidelines
• Ability to develop advanced computer skills to increase efficiency in daytoday tasks
• Good interpersonal skills and ability to work in an international team environment
• Willingness and ability to train others on study administration procedures
• Integrity and high ethical standards