Study Start-Up Assistant

As a Study Start Up Assistant you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

What you will be doing:

• Assists with administrative tasks across multiple clinical trials for the Study Start-Up team.
• Uploads and classifies essential documents to electronic Trial Master File (eTMF) accurately and on time for site greenlight.
• Performs background checks for Principal and Sub-Investigators working on Client studies.
• Manages site contacts in clinical trial management system for sites currently in Start-Up.
• May be responsible for updating metrics in clinical trial management systems.
• May assist with preparation of study Start-Up packets for clinical trial sites.
• May review essential documents for accuracy and completeness.
• Provides regular updates and escalates issues to Manager, SSU and/or SSU Specialist.
• Manages time across multiple clinical studies and escalates issues to line manager.

You are:

• Bachelor of Arts or Science (BA/BS) or equivalent or any relevant and qualifying training.
• Pharmaceutical or biotechnology industry experience, preferred.
• Knowledge of clinical Start-Up process and requirements.
• Previous Start-Up unit experience, preferred.
• Oncology clinical research experience, preferred.
• Requires effective organizational and time management skills.
• Able to multi-task under limited direction and on own initiative.
• Strong communication and inter-personal skills.
• Highly responsive and proactive, a team player.
• Knowledge of CFR and ICH/GCP requirements, preferred.
• Proficiency with Microsoft Office Products – Word, Excel, PowerPoint, SharePoint.

Why ICON?

Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

ICON, including subsidiaries, 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, colour, 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.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

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