Clinical Trial Assistant

As a Clinical Trial Assistant you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. In this role, you will support the Local Trial Manager and CRA to ensure optimal management of all documents with logistical and administrative tasks related to trial start-up, execution and closing of clinical trials. Performs regulatory document review and approval, including site specific Informed Consents. Ensures trial related activities are in compliance with GCO SOPs, policies and local regulatory requirements. May contribute to process improvement, training and mentoring of other CTA’s

Your responsibilities will include:

• Working with the Local Trial Manager and CRA to ensure overall site management and adherence to internal SOPs, policies and local regulatory requirements.
• Supports the local study team in performing site feasibility and/or country feasibility.
• Maintains site level protocol information in Trial Management Systems (e.g. CTMS).
• Ensures current versions of the required trial documents, trial-related materials and supplies are provided to the investigational site within required timeframes.
• Where applicable, works with investigational site staff to ensure accurate/complete regulatory documents are in place to expedite IEC/IRB or Health Authority (if applicable) approval process.
• Provide current and complete documents requested by the IEC/IRB and HA.
• Maintain all documents throughout the trial and post-trial in both eTMF (i.e., IF/LAF sections) and paper files.
• Distributes, collect, review, and track regulatory documents, agreements and training documentation.
• Collects and tracks Financial Disclosure information at appropriate time points.
  May contribute to process improvement including, but not limited, to representing functional area in process initiatives and contribute to optimization of daily processes.

You will need:

• A minimum of a BA/BS degree is preferred.
• Skills set corresponding with preferentially 3+ years relevant clinical trial experience or equivalent. Proficient in English language.
• Strong knowledge with MS Office (Word, Excel, Access, Outlook , Explorer and PowerPoint)
• Strong interpersonal and negotiating skills.
• Excellent organizational skills and the ability to collaborate and handle multiple priorities within a matrix environment.
• Perform activities in a timely and accurate manner.

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.