Job Description

Overview

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.

Responsibilities

The Senior Clinical Trial Associate will be responsible for setting up, tracking and maintaining Clinical Site related documents. You will help manage and review regulatory documents as well as maintain the Local Study File. Assist with coordinating the distribution, retrieval and review of regulatory documents required for the initiation of the Clinical Study, through maintainence, and close-out.

Performs the role of Clinical Trial Assistant (CTA) supporting the Local Trial Manager and Site Manager 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\xe2\x80\x99s.

Qualifications

What do you need to have?

• At least 2 years of related experience
• Bachelor\xe2\x80\x99s Degree preferred in scientific/medical discipline or equivalent experience.
• Experience with clinical trials required
• Experience with study start-up, maintanance, close-out of clinical studies
• Demonstrated expertise and experience Clinical Trial Coordination
• Ability to maintain Clinical Trial Tracking systems.
• Exhibits proficiency in managing multiple projects and deliverables with competing priorities.
• Read write and speak fluent English
• To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.

Benefits of Working in ICON:

Our success depends on the knowledge, capabilities and quality of our people. That\xe2\x80\x99s why we are committed to developing our employees in a continuous learning culture \xe2\x80\x93 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.

ICON