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
Managing sponsor generated queries
Taking responsibility for study cost effectiveness
Preparation and review of study documentation and feasibility studies for new proposals
Potential to assist in training and mentoring fellow CRAs
Maintain timelines . Ensure accuracy and completeness of data entered into ICON systems.
Independent and proactive coordination of all the necessary activities required to set up and monitor a study , including but not limited to the following : Identify investigators.
Help when requested , in preparation of regulatory submissions . Design of patient information sheets and consent forms .
Ensure timely submission of protocol / consent documents for ethics / IRB approval. Pre study / placement and initiation visits.
What you need
University degree in medicine, science, or equivalent
At least 12 months of Independent / On-site monitoring experience is required
Previous monitoring experience in medium 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 at least 60% of the time
Why join us?
Ongoing development is vital to us, and as a CRA you will have the opportunity to progress your career, with the potential to move into other related areas to enhance your skill set.
Our benefits package is competitive, our scope is international and we genuinely care about our people and their success.
ICON Plc is an equal opportunity employer. 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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