In-House CRA

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.

• One per study/one per region
• Actively contribute to site audit readiness through back-up activities with the primary site CRA, including but not limited to: periodic eTMF review, collection of documents from the site, escalation of identified issues, CTMS up-to-date, etc.
• Collect and review site essential documents and update Regulatory Document Tracker
• Send reminders and/or CTMS reports to CRAs re: open follow up items, protocol deviations, and quality issues
• Support CRAs to ensure all site supplies are available on site for site initiation visits
• Support requests from CRAs while they are onsite (document retrieval, vendor questions)
• Support site training documentation collection and tracking of training documentation
• Support in maintaining compliance of sponsor systems i.e., CTMS, TMF, Trifecta, etc.
• Follow-up on outstanding site issues to resolution and/or document attempts to resolve issues upon closure of clinical trial sites
• Undertake project related admin tasks to support the Lead CRA, i.e., meeting minutes, tracking, site document preparation
• May attend clinical trial site co-monitoring visits to support clinical trial activities such as ISF/eTMF reconciliation and audit preparation, as needed.
• Attends Investigator Meetings and study-specific training for assigned trials

Benefits of Working in 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.

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, color, 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.