Wilmington, DE
Contract Duration: 11-36 months
Rate: Negotiable
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 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 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 ICH-GCP, Company Procedural Documents. Review and process start up documents, including Sub Investigator's documents in compliance with ICH-GCP, Company 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 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 multi-task in a high-volume 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 Start-up, together with an understanding of
the ICH/GCP 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
