Icon plc is a world-leading healthcare intelligence and clinical research organisationFrom 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 successIcon people have a mission to succeed and a passion that ensures what we do, we do well.
Responsibilities
What will you be doing?
You will be responsible for setting up, tracking and maintaining clinical site related documentsYou will help manage and review regulatory documents as well as maintain the local study fileAssist 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 trialsPerforms regulatory document review and approval, including site specific informed consentsEnsures trial related activities are in compliance with gco sops, policies and local regulatory requirementsMay contribute to process improvement, training and mentoring of other cta’s.
Demonstrated expertise and experience in the clinical trial coordination
Ability to maintain clinical trial tracking systems.
Exhibits proficiency in managing multiple projects and deliverables with competing priorities.
Bachelor’s degree preferred in scientific/medical discipline or equivalent experience.
Read write and speak fluent english
Familiarity with working in service industry or project management environment.
Qualifications
What do you need to have?
4 yr degree highly preferred or equivalent industry experience
At least 2 years of related clinical trial experience required
Experience with study start-up, maintanance, close-out of clinical studies
Prior experience using computerized information systems.
Read, write, and speak fluent english; fluent in host country language required
Regulatory document review experience
Irb and site contact experience
Commutable to blue bell, pa or raleigh, nc location twice a year
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 peopleThat’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 programsIn 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 harassmentAll 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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