ICON Strategic Solutions · 12 hours ago
Clinical Trial Assistant, TMF
United States
Full-time
Remote
Mid LevelICON plc is a world-leading healthcare intelligence and clinical research organization. They are currently seeking a Clinical Trial Assistant (CTA) to support Trial Master File (TMF) operations, focusing on eTMF quality control and content integrity. The role involves administrative support for clinical trials, regulatory document preparation, and collaboration with cross-functional teams to ensure compliance and trial success.
Pharmaceuticals
Responsibilities
Providing administrative support for clinical trials, including managing documentation, coordinating meetings, and maintaining trial-related records
Assisting in the preparation and submission of regulatory documents and ensuring compliance with study protocols and regulatory requirements
Collaborating with cross-functional teams to support trial operations and resolve any issues that arise during the course of the study
Monitoring and tracking trial progress, including managing site communications and ensuring timely delivery of study materials
Building and maintaining strong relationships with site staff and other stakeholders to facilitate smooth trial operations and support overall project success
Perform hands-on eTMF quality control (QC) reviews, including detailed assessment of TMF content accuracy, completeness, and compliance across individual sections
Ensure cross-document consistency and integrity by evaluating relationships, correlations, and alignment across TMF components to support overall inspection readiness
Qualification
Required
Bachelor's degree or relevant certification in life sciences, healthcare, or clinical research highly preferred
Extensive experience in a clinical trial support role, with a solid understanding of clinical trial processes and regulatory requirements
Strong organizational and multitasking skills, with the ability to manage multiple tasks and projects effectively
Proficiency in clinical trial management systems and relevant software, with a keen eye for detail in documentation and data management
Excellent communication, interpersonal, and problem-solving skills, with the ability to work collaboratively with diverse teams and stakeholders
Demonstrated experience performing hands-on eTMF/TMF quality control reviews, including content quality assessment beyond basic administrative checks
Strong knowledge of TMF structure, regulatory expectations, and cross-document consistency requirements, with the ability to identify gaps, discrepancies, and quality risks
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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