CTA

ICON is a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. We specialize in the strategic development, management and analysis of programs that support Clinical Development - from compound selection to Phase I-IV clinical studies. We started as a team of 5 members in 1990 & today we are ranking at top 4 worldwide based on revenue of 2015. Currently we have 12200+ employees across the globe. ICON is a $1.575bn company having its presence across 89 offices in 37 countries.

Title: Clinical Trial Assistant 

Location: Chennai

Job Summary :

To be an integral part of the study team by providing administrative and project tracking support to the Project Manager(s) and Clinical Trial Manager(s) with emphasis on supporting inspection readiness

• 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