Clinical Study Administrator

Role Overview

• Assists in coordination and administration of clinical studies from the start-up to execution and close-out.
• Collects, assists in preparation, reviews and tracks documents for the application process.
• Interfaces with Investigators, external service providers and CRAs during the document collection process.
• Serves as local administrative main contact and works closely with the CRAs and/or the LSAD for the duration of the study.
• Operational responsibility for the correct set-up and maintenance of the local eTMF and ISF including document tracking.
• Ensures essential documents under their responsibility are uploaded in a timely manner to maintain the eTMF "Inspection Readiness".
• Ensures that all study documents are ready for final archiving and completion of local part of the eTMF.
• Contributes to the production and maintenance of study documents.
• Creates and/or imports clinical-regulatory documents into the Global Electronic Management System.
• Contributes to electronic applications/submissions by handling clinical-regulatory documents.
• Sets-up, populates and accurately maintains information in client’s tracking and communication tools.
• Prepares and/or supports contract preparation at a site level.
• Manages and contributes to coordination and tracking of study materials and equipment.
• Coordinates administrative tasks during the study process, audits and regulatory inspections.
• Leads the practical arrangements and contributes to the preparation of internal and external meetings.
• Prepares, contributes to and distributes presentation material for meetings, newsletters and web-sites.
• Responsible for layout and language control, copying and distribution of documents.
• Responsible for printing and distribution of documents such as letters and meeting minutes.
• Interfaces with Data Management Centre to facilitate the delivery of study related documents/material.
• Ensures compliance with client ’s Code of Ethics and company policies and procedures.

Requirements

• High school/Secondary school qualifications
• Previous administrative experience preferably in the medical/ life science field
• Proven organizational and administrative skills
• Computer proficiency
• Good knowledge of spoken and written English
• Further studies in administration and/or in life science field are desirable
• Ability to develop advanced computer skills to increase efficiency in daily tasks
• 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
• 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
• Integrity and high ethical standards.

Benefits

• Health insurance
• Retirement plans
• Paid time off
• Flexible work arrangements
• Professional development