Recognize, exemplify and adhere to ICON's values which center around our commitment to People, Clients and Performance. 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 60%) domestic and/or international. *Familiarity with ICON's SOPs/WPs, ICH-GCP and appropriate regulations. Familiarity with ICON systems. *Maintain timelines.
Ensure accuracy and completeness of data entered into ICON systems. Familiarity with principles of investigator recruitment. *Assist with coordinating all the necessary activities required
Assist with coordinating all the necessary activities required to set up and monitor a study, including the following : Identify investigators. Help, when requested, in preparation of regulatory submissions.
Design patient information sheets and consent forms. Coordinate documents translation, verification and back translations where required. Ensure timely submission of protocol/consent documents/safety reports for Ethics/IRB approval according to local requirements.
Pre-study/placement and initiation visits. Conduct regular monitoring visits in accordance with the ICON site monitoring SOP/Sponsor site monitoring SOP/WP as appropriate.Maintain all files and documentation pertaining to studies. Motivate investigators in order to achieve recruitment targets.
Complete accurate study status reports. Ensure the correct storage of drugs and the diligent account of all drugs in accordance with SOPs. Keep the Project Manager regularly informed.
Process case record forms to the required quality standards and timelines . Deal with sponsor generated queries in a timely manner. Ensure the satisfactory close-out of investigator sites. Ensure correct archiving of files on completion of a study.
Co-operate with sponsor and/or ICON QA personnel in the conduct of QA audits. Participate in feasibility studies for new proposals, as required Maintain patient and sponsor confidentiality . lnvestigational Products (IPs) stored and managed by the site: Ensure storage conditions and acceptable supplies are provided Ensure IPs are supplied only to eligible patients Ensure IP receipt, use and return are controlled and documented Ensure disposition of unused IP comply with regulatory requirement and are in accordance with the sponsor.
To participate, if requested, in the preparation of and review of study documentation e.g., draft protocols, draft CRFs, monitoring guidelines and elements of final report. Participate in data listing reviews, as applicable. *To be cost effective. Ass ist with marketing the company if and when appropriate. Other duties as assigned.