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- Recognize, exemplify and adhere to ICON's values which center around excellence in execution, exceeding expectations, and enhancing relationships
- As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs Travel (approximately 10%) domestic and/or international
- To possess a knowledge of ICH GCP, appropriate regulations, relevant ICON SOPs, ICON internal tracking systems, and Client SOPs / Client systems (when applicable)
- To assist the project teams with the set-up, organization and maintenance of clinical study documentation (e.g. Study Files, CRFs, etc.) and guidelines (as appropriate) including preparation for internal/external audits, final reconciliation and archival
- To assist in the processing of Data Collection Forms i.e. log in, tracking, quality control as appropriate for the study
- To share responsibility in the quality control audits of clinical study documentation (e.g. Study Files, CRF Files, Monitoring Files, etc.) to ensure study files are inspection ready at all times
- To facilitate and coordinate ordering/dispatch and tracking of trial materials (e.g. CRFs, diary cards, lab supplies, drug supplies, and study binders) as appropriate
- To assist project teams with trial progress tracking by updating the Clinical Trial Management systems, providing access to study/client systems (as appropriate)
- To run, review and analyze study reports for accuracy and work with the project teams to ensure updates are completed correctly
- To assist in coordination of study related payments, if applicable
- To contact and serve as a contact for clinical sites for basic requests (e.g., enrollment updates, missing documentation, meeting arrangements, etc.)
- To assist in the tracking and distribution of safety reports To coordinate document translation, if required To assist and attend the Project team with meeting coordination, activities preparation, generation of meeting minutes and agendas
- To assist in the production of slides, overheads, etc., as needed for project, departmental, sponsor and/or business development presentations
- To assist with the coordination of various tracking reports, including but not limited to, team member tracking and training To work in collaboration with internal and external colleagues to meet project objectives and timelines
- To Keep the Project Manager / Project Director / Clinical Operations Designee informed of any issues within the Project Team which require attention To maintain client and patient confidentiality Other duties as assigned
A better career. A better world. A better you.
Our people are our greatest strength, are the core of our culture and the driving force behind our success. Throughout all levels of the company, our people have a drive to succeed and a passion that ensures what we do, we do well. We help you build exciting and rewarding careers, deliver results to help bring life-changing medicine and devices to market and maintain ICON’s success as an industry leader. See all locations Read more
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