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.
Overview:
As a Clinical Research Associate II you will coordinate all aspects of the clinical monitoring and site management process in accordance with regulatory guidelines, local regulations and standard operating procedures.
In this role you will be a decision maker, solving problems independently or as part of the client and ICON team.
You will be managing competing priorities, supporting the on-site team, ensuring investigators follow the clinical trial protocol, providing training, and most importantly, motivating the team to ensure high quality results.
Key responsibilities:
- You will have the opportunity to monitor multiple Phase I, II, III & IV clinical trial sites, across different therapeutic areas, particularly in Oncology studies.
- Assist other CRAs with co-monitoring activities both remote and on-site.
- You will utilise your customer service mindset with your sites focusing on delivering value, building loyalty and trust to create a positive impact and strong relationship with investigators and study coordinators where respect, knowledge and commitment to ICH/GCP guidelines are key to successful trial conduct.
- As the CRA you are the main sponsor representative, providing key project updates.
You will collaborate with the team, developing commitment to study timelines and objectives through regular visits with site staff in-person and remotely.
- You will be first to review "source to CRF/eCRF," ensuring patient safety and data integrity aspect of the study.
- As the first point of contact for study sites, escalating any concerns/issues to other departments including Safety, Investigational Medicinal Product, Local Study Managers and management team as appropriate.
- Additionally, you will oversee the sites' adherence to GCP/ICH practices, ensuring quality of study conduct.
Required experience and qualifications:
- Bachelor's Degree (or equivalent) with minimum 2 years or more of relevant healthcare monitoring experience in the pharma or clinical research industry.
- Proficiency with medical terminology
- Working knowledge of Local Regulations
- A demonstrated working knowledge of ICH/GCP Guidelines
- Excellent record-keeping skills and attention to detail
- Experience conducting Site Selection, Initiation, Routine Monitoring and Close Out Visits both remotely and on-site
- Strong technical skills with CTMS, eCRF, eTMF
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.
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