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ICON Strategic Solutions · 7 hours ago

Clinical Study Administrator (CTA level)

Wilmington, DE

Full-time

Hybrid

New Grad, Entry Level

ICON plc is a world-leading healthcare intelligence and clinical research organization. They are seeking a Clinical Study Administrator to support the application process and manage documentation for clinical trials, ensuring compliance with regulatory requirements and maintaining inspection readiness.

Responsibilities

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

Qualification

Clinical trial supportETMF experience in VeevaICH/GCPVendor managementComputer proficiencyCommunication skillsOrganizational skillsInterpersonal skillsTeam orientedAttention to detail

Required

Industry experience in clinical trial support required (CRO/Pharma)

BS/BA degree with relevant clinical trial experience

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

Benefits

Various annual leave entitlements

A range of health insurance offerings to suit you and your family’s needs.

Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.

Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.

Life assurance

Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.