Clinical Study Specialist
1800 Concord Pike Wilmington, DE 19805
Clinical Study Specialist
This role assists in the coordination and administration of site start up for assigned studies. This role ensures quality and consistency of site activation deliverables to time, cost and quality objectives. The Clinical Study Specialist is responsible for ensuring vendor spreadsheets are completed correctly and processed (submitted to vendor or global team) according to study team guidelines. This role is responsible for reviewing and processing all sub Investigator documents. The Specialist will attend weekly Study Team meetings to report on vendor spreadsheets, sub I document progression, etc.
• Assist SATS with obtaining and maintaining essential documents in compliance with ICH-GCP, Procedural Documents.
• Review and process start up documents, including Sub Investigator’ s documents in compliance with ICH-GCP, 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 weekly study team meetings and be prepared to provide a report on vendor spreadsheet status and sub I document status.
• Update IMPACT and other systems with data from centers as required per SAT process.
• Create and/or import clinical-regulatory documents into the A New Global Electronic Library (ANGEL) according to the Global Document List (GDL) ensuring compliance with the Authoring Guide for Regulatory Documents to support publishing in ANGEL
• Set-up, populate and accurately maintain information in tracking and communication tools (e.g. IMPACT, 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.
• 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 it, together with an understanding of the ICH/GCP guidelines
• Ability to develop advanced computer skills to increase efficiency in day-to-day tasks
• Very good verbal and written communication
• 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