- 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.
- 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
- 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.
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Clinical Study Administrator - Wilmington - ICON
Description
Clinical Trial Associate (Clinical Study Administrator)
ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development
What You Will Be Doing:
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON 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 or submit a request here.
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.
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