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
