In House CRA
- Italy
- Clinical Monitoring
- ICON Strategic Solutions
- Remote
TA Business Partner
- Icon Strategic Solutions
About the role
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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.
The In-House CRA will be dedicated to one of our global pharmaceutical clients with whom ICON shares a culture of innovation, flexibility and a common vision of bringing life-improving drugs to market.
Key responsibilities include:
- Consistent and collaborative communication to internal and external partners (CRO, Laboratory, etc.).
- Ensure optimal management and filing 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.
- Creation and sending communications materials to countries and/or study sites (e.g. Newsletters, study document updates).
- Preparing essential clinical trial documentation, distributing, tracking and filing of documents on return.
- Submission of IRB – IEC documents for approval.
- Coordination of communication of project/study status to various levels of management.
- Managing and maintaining study information documents & trial supplies e.g.; Patient Information Sheets, Patient Diaries, Lab Kits & Medical equipment for sites.
- Support the teams with ongoing conduct of studies.
You are:
Dedicated, collaborative and inspire others.
Here at ICON we want our employees to succeed and ensure that they are set up for this success through constant training, development and support. To enable success in this position you will have:
- A minimum of a BA/BS degree is preferred. Skills set corresponding with preferentially 2+ years relevant clinical trial experience or equivalent.
- Strong knowledge with MS Office (Word, Excel, Access, Outlook , Explorer and PowerPoint).
- Strong interpersonal and negotiating skills.
- Excellent organizational skills and the ability to collaborate and handle multiple priorities within a matrix environment.
- Perform activities in a timely and accurate manner.
- Proficient in Italian and English language.
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.
Impactful work. Meaningful careers. Quality rewards.
At ICON, our employees are our greatest strength. That’s why we are committed to empowering you to live your best life, both inside and outside of work. Whether your ambition is lead a global team, become a deep scientific or technical expert, work in-house with our customers or gain experience in a variety of different ICON functions, we will support you in realising your full potential. See all locations Learn more about Our Culture at ICON
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