CRA II

As a CRA you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

• Identify, select, initiate and closeout appropriate investigational sites for clinical studies.
• Monitor those sites in order to ensure that studies are carried out according to the study protocol and in accordance with ICON SOPs / WPs applicable regulations and the principles of ICH-GCP.
• Provide a benchmark of monitoring competence to inexperienced / less-experienced colleagues.

What you will be doing :

o Identify investigators.

o Help when requested, in preparation of regulatory submissions. Design of patient information sheets and consent forms.

o Ensure timely submission of protocol / consent documents for ethics / IRB approval. Pre study / placement and initiation visits. Conduct regular monitoring visits in accordance with the ICON site monitoring SOP / sponsor site monitoring SOP, as appropriate

o Ensure storage conditions and acceptable supplies are provided

o Ensure IPs are supplied only to eligible patients

o Ensure IP receipt, use and return are controlled and documented

o Ensure disposition of unused IP comply with regulatory requirement and are in accordance with the sponsor.

o Act in a lead role on a study assuming additional responsibilities as detailed / documented by the Project Manager if appropriate

You are : BA / BS degree.

Degree in a health or science related field.

2 years of clinical trial monitoring experience.

Specific therapeutic area experience depending on the services need.

Strong working knowledge of ICH GCP, company standard operating procedures, local laws and

regulations, assigned protocols and associated protocol specific procedures including

monitoring guidelines.

Strong IT skills in appropriate software and company systems.

Willingness to travel with overnight stay away from home according to business needs.

What ICON can offer you :

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include :

Visit our careers website to read more about the benefits of working at ICON : https : / / careers.iconplc.com / benefits

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON 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 through the form below.

https : / / careers.iconplc.com / reasonable-accommodations

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.