Clinical Trial Assistant

The Site Management Associate I (SMA I) is responsible for managing, implementing and monitoring clinical studies, with support , in a team setting according to ICON SOPs, SSPs and all applicable rules and regulations.

The responsibilities of this position include, but are not limited to: identifying, training/initiating and closing out study sites; conducting remote site monitoring visits and/or targeted on-site visits as needed, conducting remote site management activities, managing study sites and the required protocols, amendments and/or deviations, assuring that data is reported accurately and timelines are maintained.

• 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
• 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

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.

• 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, Life Works, 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…