Clinical Trial Assistant

Overview

Clinical Trial Assistant

Location: Sydney (hybrid)

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

With our patients at the centre 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.

Within this client dedicated program you will thrive within a fast-paced, dynamic study design. As we are fully embedded with this global pharmaceutical client, you will experience a true “one team” approach.

Frequent, consistent communication, both internally and with our client, positions our program to be closely aligned on our shared goals.

Responsibilities

What you will be doing:

• Support the Clinical Trial Managers and CRAs to ensure optimal management of all documents with logistical and administrative tasks related to trial start-up, execution and closing of clinical trials
• Regular document review and approval, including site specific Informed Consents as well as ensuring trial related activities are in compliance with GCO SOPs, policies and local regulatory requirements
• Organize meetings, take minutes and provide administrative support for investigator meetings
• Track and update study metrics
• Setup and maintain TMF/eTMF, documents collection and quality check
• Support the study team with distribution of site materials and equipment
• This role may also contribute to process improvement, training and mentoring of other CTA’s

Qualifications

You are:

• A minimum of a BA/BS degree is preferred.
• 2 years relevant clinical trial experience, preferrably previous CTA experience within a pharmaceutical/ biotechnology or CRO organization
• Basic knowledge and understanding of Essential Documents, CFR and GCP/ICH
• Proficiency with technological systems (Microsoft Office, TMF, CTMS,)
• Fundamental understanding of filing systems and organizational tools
• 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.

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