- Independent, proactive work to set up and monitor studies, complete reports and maintain documentation
- Submitting protocol, consent documents for ethics/IRB approval, as well as preparing regulatory submissions
- Balancing sponsor generated queries
- Taking responsibility for study cost efficiency
- Preparation and review of study documentation and feasibility studies for new proposals
- Potential to assist in training and mentoring fellow CRAs
- 2 years + of certified monitoring experience in phase I-III trials as a CRA (for a CRA II position). For a Senior CRA, 3 years + experience is required
- 4 year college degree in medicine, science, or equivalent
- Previous monitoring experience in medium and large -sized studies, including study start-up and close-out
- Knowledge of ICH-GCP guidelines and ability to review and evaluate medical data
- Excellent written and verbal communication
- Ability to work to tight deadlines
- Availability to travel (domestic fly and drive) and should possess a valid driving license
- Fluent Italian and English
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Senior Cra - Milano, Italia - Icon
Descrizione
About the role 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.
As aClinical Research Associateat ICON (full service), you'll work within a large-scale, fast-paced environment alongside a close-knit team of highly qualified CRAs to identify, select, initiate and close-out investigational sites for clinical studies in phases II – IV, ensuring adherence to applicable regulations and principles of ICH-GCP.
The role:
You will need:
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.
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, 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.
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