ICON Strategic Solutions · 1 day ago
Clinical Trial Assistant
Wilmington, DE
Full-time
Hybrid
New Grad, Entry LevelICON Strategic Solutions is a leading organization in clinical trial support, seeking a Site Management Associate I to manage and monitor clinical studies. The role involves coordinating study sites, ensuring compliance with protocols, and managing documentation for regulatory submissions.
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
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.
Company
ICON Strategic Solutions
ICON Strategic Solutions is the global leading provider of Functional Service Provision (FSP) services.
10001+ employees
H1B Sponsorship
ICON Strategic Solutions has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (1)
2022 (1)
2021 (2)
2020 (3)
Funding
Current Stage
Late StageLeadership Team
Jennifer Alamo Linnell
VP, HR Business Partnering
Aimée Guzmán
External Partnerships Project Manager & Site Lead | Providing Services for J&J Innovative Medicines
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