Clinical Trial Assistant

ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organization's.

With our patients at the center of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.

Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

ICON Poland are currently recruiting for an experienced Clinical Trial Assistant to work on a range of key therapy areas of Cardiovascular, Renal & Metabolism, Oncology and Neuroscience. This particular role is a client dedicated one where you will work exclusively on one sponsors trials and SOPs; you will work for a client that values their staff and puts an emphasis on career development.

The Clinical Trial Associate (CTA) supports CRAs and Clinical Trial Managers in assigned studies during set-up and whole study lifecycle in compliance with sponsors' processes, GCP/ICH and regulatory requirements.

Key responsibilities:

• Supports document collection, preparation, and adaption for submission to IRB/EC and Health Authorities as applicable
• Systems's set-up
• Supports vendor selection and supports vendor set-up as applicable
• IF and TMF management (country and site TMF); set-up and maintenance according to regulatory and sponsor's requirements;
• Document oversight and tracking
• Ensures all documentation is in place for initial and subsequent drug release in collaboration with the local Qualified Person(s)
• Supports preparation and translation of ICF into local languages (including vendor management if necessary)
• Supports preparation of patient facing material
• Responsible for completeness of uploaded trial related documents, including archiving of paper TMFs
• Supports country SSU strategy in close collaboration with SSU Team to ensure SSU timelines and deliverables are met according to country commitments
• Ensures adherence to financial standards, prevailing legislation, ICH/GCP, IRB/IEC, Health Authority and SOP requirements
• Provides logistic support to SSU team, CRA, Project Managers, Clinical Trial Managers in all phases of the clinical trials

To be successful in the role, you will have:

• University degree
• Minimum 1 year of experience as a CTA gained at CRO or pharmaceutical company or experience in a similar role in clinical trials
• A demonstrated working knowledge of ICH/GCP Guidelines

• Proven organizational and administrative skills.

• Computer proficiency.

• Good knowledge of spoken and written English.

Benefits of Working in ICON:

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.

At 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.

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, 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.

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