ICON plc

Clinical Study Administrator – CTA Level

ICON plc

full-time

Posted on:

Location Type: Hybrid

Location: Wilmington • 🇺🇸 United States

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Job Level

Mid-LevelSenior

Tech Stack

Google Cloud Platform

About the role

  • 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.

Requirements

  • 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, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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, subsidised travel passes, health assessments, among others.

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
clinical trial supportdocument trackingeTMFISFSubmission Ready Standards (SRS)clinical-regulatory documentsvendor managementcomputer proficiencyattention to detailtime management
Soft skills
verbal communicationwritten communicationorganizational skillsteam orientedflexibilityinterpersonal skillsintegrityhigh ethical standardsability to multi-taskability to train others