Study Start Up Clinical Study Administrator

STUDY START UP CLINICAL STUDY ADMINISTRATOR WILMINGTON, DE MUST be able to work in the Wilmington office a minimum of 3 days per week. Project Description:

• SSU CSA is responsible for ensuring vendor spreadsheets are completed correctly and processed (submitted to vendor or global team) according to study team guidelines.
• SSU CSA is responsible for reviewing and processing all sub-Investigator 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 client's Procedural Documents, international guidelines such as ICH and Google Cloud Platform 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 ICH-Google Cloud Platform, client's Procedural Documents.
• Review and process start up documents, including Sub Investigator's documents in compliance with ICH-Google Cloud Platform, client's Procedural Documents.
• Drive delivery of regulatory documents at the sites. Proactively identify delays in start- up 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.
• Set-up, populate and accurately maintain information in client's tracking and communication tools (e.g., Veeva Clinical, Box, etc.) and support others in the usage of these systems.

• 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.
• Previous administrative experience .
• 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 multi-task in a high-volume environment with shifting priorities .
• Team oriented and flexible; ability to respond quickly to shifting demands and opportunities .
• Working knowledge of the Clinical Study Process and an understanding of the range of working procedures relating to study Start-up, together with an understanding of the ICH/Google Cloud Platform guidelines.
• Ability to develop advanced computer skills to increase efficiency in day-to-day 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 .
• Regulatory documents review, uploading and indexing documents in Veeva, Vendors management.
• Strong communication and organizational skills.
• Experience with reviewing regulatory documents, Veeva eTMF experience, vendor management, strong verbal & written communication skills, strong organizational skills.