Clinical Research Associate
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.
• Contribute to the identification of new sites for clinical trials; analyse capability and support CRMA and CSM in making recommendation for trial inclusion.
• Assume ambassadorial role to facilitate communication between sites and the Client CPO to increase value proposition to investigators.
•Facilitate the preparation and collection of site and country level documents during all phases of the trial. Supports the CSM in the oversight of Country and Site Trial Master Files (TMF). During all phases of the trial ensure archiving per relevant SOP.
•Negotiate investigator remuneration; prepare financial contracts between Novartis and investigational sites and investigators. Ensure adherence to payment schedule.
• Execute site initiation and training, generate initiation visit report.
• Study Execution
• Implement complete site management including monitoring visits, regulatory assessment, drug supply management, etc. to ensure compliance with protocol, GCP, global and local regulations, global and local processes.
• Identify problems at sites; resolve issues and escalate as appropriate.
• Collaborate with the CSM to ensure recruitment and execute contingency plans, as needed.
• Complete preparation and generation of visit monitoring reports as per relevant SOP
• Review and manage data at site; resolve technical and content issues on a continuous basis in order to achieve timely database lock targets.
•If working with central CRAs (blinded and un-blinded), respond to alerts and follow-up to ensure resolution of issues
• Implement site close-out activities and generate site close-out report.
• Provide feedback on site performance for future trial site feasibility/selection
To be successful in the role, you will have:
• Degree (BA/BS/BSc) in life sciences or qualified nurse preferable
• From 0 to 1 year CRA experience gained within the industry as a Clinical Research Associate (CRA) either in Clinical Research Organisation (CRO) or pharmaceutical industry or investigational site
• Experience of clinical trial set up and contract negotiation preferred, but not essential
• EDC working experience
• Full-time availability