Senior Clinical Trial Assistant

ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives.

Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.

That’s our vision. We’re driven by it. And we need talented people who share it.
If you’re as driven as we are, join us. You’ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry.

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 solid understanding and working knowledge of ICH GCP, appropriate regulations, relevant ICON SOPs, ICON internal tracking systems and client SOPs I client systems (when applicable)
• *To be a primary lead in 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 drive 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
• *T9 take a lead role in the initiation and facilitation of ordering/dispatching and tracking of trial materials (e.g. CRFs, diary cards, lab supplies, drug suppl ies) as appropriate with minimal to no supervision required by the PM/CTM
• *To proactively facilitate project teams with trial progress tracking by updating the Clinical Trial Management systems, providing access to systems and addressing any discrepancies with minimal superv ision
• To independently and proactively run, review and analyze study reports for accuracy and work with the project teams to ensure updates are completed correctly
• To assist in verification and co-ordination 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 track and distribute safety reports with minimal to no oversight by PM/CTM
• To co-ordinate document translation, if required
.. To serve as the primary lead in the coordination of meetings/attend the meetings, preparation activities and the generation of meeting agenda and minutes with minimal to no supervision and regularly attend and contribute to project specific and departmental meetings
• To be the primary lead in the production of slides, overheads, etc., as needed for project, departmental, client and/or business development presentations
• To lead 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, timelines, and budgets, where appropriate
• *To mentor and train new and less experienced Clinical Trial Assistants (CTAs), including identification of training needs
• *To keep the Project Manager I Project Director I Clinical Operations Designee informed of any issues within the Project Team which require attention
• To serve as a leading contributo r to the development of the File Management Plan
• *To effectively anticipate the needs of the study team and require minimal oversight/instruction from the CTM(s)/PM(s) for tasks
• To proactively create study templates, tools, and tracking methods for the study teams
• To demonstrate resourcefulness, make appropriate use of available technology and tools in seeking and implementing solutions
• *To assist proactively in the set-up of trial systems during study start up
• To maintain client and patient confidentiality
• Other duties as assigned

Benefits of Working in ICON:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a culture that rewards high performance and nurtures talent.

We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals – both ours and yours.
We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans – and related benefits such as life assurance – so you can save and plan with confidence for the years ahead.
But beyond the competitive salaries and comprehensive benefits, you’ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.

ICON is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.