Clinical Study Administrator (Wilmington DE)

Overview

ICON is looking for a CTA level candidate for one of our major FSPs!

Responsibilities

Your responsibilities include:

• Collects, assists in preparation, reviews and tracks documents for the application process. Assists in timely submission of proper application/documents to EC/IRB and, where appropriate to Regulatory Authorities for the duration of the study.
• Interfaces with Investigators, external service providers and CRAs during the document collection process to support effective delivery of a study and its documents.
• 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 in accordance with ICH-GCP and local requirements.
• 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 eTM and supports the CRA in the close out activities for the ISF.
• Contributes to the production and maintenance of study documents, ensuring template and version compliance.
• Creates and/or imports clinical-regulatory documents into the Global Electronic Management System
• Contributes to   electronic  applications/submissions  by  handling   clinical-regulatory  documents according to the requested technical standards i.e., Submission Ready Standards (SRS), supporting effective publishing and delivery to regulatory authorities.

Qualifications

Your qualifications

• BS/BA degree wiht relevant clinical trial experience 
• Industry expereince in clinical trial support required (CRO/Pharma)
• Experience with vendor management, strong verbal & written communication skills,
• and strong organizational skills
• Previous administrative experience
• Proven organizational and administrative skills
• Computer proficiency
• 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/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
• eTMF experience in Veeva required
• Must be located in a commutable distance from Wilmington, DE and open to a hybrid (home/office-based) role

Compensation will be determined based on factors such as geographic location, work experience, education/training, and skill level

Benefits of Working in ICON:revious administrative experience preferably in the medical/ life science field

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.