About the role
As a Clinical Research Associate (CRA) 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.
What you will be doing:
- You will monitor multiple Phase I, II, III & IV clinical trial sites, across different therapeutic areas. 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.
You are:
- Bachelor’s Degree (or equivalent) with 2-4 years of relevant healthcare experience in the pharma or clinical research industry. Minimum 6-12 months of monitoring and site management experience
- Scientific background
- 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
- Fluent in English, both written and oral
- Strong technical skills with CTMS, eCRF, eTMF
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.
A better career. A better world. A better you.
Our people are our greatest strength, are the core of our culture and the driving force behind our success. Throughout all levels of the company, our people have a drive to succeed and a passion that ensures what we do, we do well. We help you build exciting and rewarding careers, deliver results to help bring life-changing medicine and devices to market and maintain ICON’s success as an industry leader. See all locations Read more
Day in the life
Teaser label
Our PeopleContent type
BlogsPublish date
08/29/2023
Summary
To excel as a Clinical Research Associate (CRA) in a Clinical Research Organization (CRO), you need a combination of education, skills, and the right mindset. Brazil-based CRA II Debora shares her
Teaser label
Our PeopleContent type
BlogsPublish date
05/23/2023
Summary
How to progress as a Clinical Research AssociateTo thrive as a Clinical Research Associate (CRA), it is imperative to cultivate a multifaceted skill set and demonstrate unwavering commitment to exce
Teaser label
A Day In The LifeContent type
BlogsPublish date
04/05/2023
Summary
Senior Clinical Research Associate Suzaita Hipolito talks about the satisfaction gained from working in Clinical Research. “What would it look like to wake up every day feeling happy and fulfilled?
by
Suzaita Hipolito
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