• Recognize, exemplify and adhere to ICON's values which center around our culture of accountability, integrity, partnership, collaboration and excellence in delivery.
• 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
• This is a developmental role which requires extensive training.An ability and willingness to travel (drive and fly) as needed for this role and at least 60% of the time for future roles is required.
• *To acquire knowledge of ICH GCP, the conduct of clinical trials and governing 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/dispatching 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 site/ 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 with, and attend the Project team meetings, and corresponding 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 status and 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
Required:
• Bachelor's degree or local equivalent, in life sciences or related discipline
• Fluent English Level
OFFICE BASED POSITION
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