.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.Primary Responsibilities Completes onsite and remote monitoring activities in accordance with all ICH-GCP guidelines, applicable regulations, SOPs, and study processes. Activities include qualifying potential investigative sites, initiating clinical trials, maintaining study files, and providing instructions to site personnel and study close out.Verifies the protection of study participants by confirming informed consent procedures and protocol have been performed in accordance to applicable regulations.Ensures the integrity of clinical data and that the study is conducted in compliance with the approved protocol, GCP, applicable regulations, and SOPs.Verifies proper management and accountability of Investigational Product (IP).Writes and submits reports of investigational site findings and updates applicable tracking systems. Escalates observed deficiencies, issues, and corrective and preventative action plans as appropriate.Manages essential documents as required by local regulations and ICH-GCP guidelines before, during, and after a clinical study; assists with resolutionof investigational site/data queries.Performs key risk assessment and management responsibilities throughout the project, including key risk indicator and site health analysis, site process evaluation, and project escalation.Participates in audit preparation and follow-up activities as needed.Independently performs a limited range of onsite and offsite monitoring visit types.Gathers and reviews information for assigned sites and identifies inconsistencies. With guidance from project and functional management, assesses risk and escalates as appropriate.Independently performs a variety of onsite and offsite monitoring visit types.Gathers and reviews information for assigned sites and identifies inconsistencies. With limited guidance from project and functional management, assesses risk and escalates as appropriate.Assists with non-complex ad hoc, short-term assignments in support of additional studies or departmental initiatives
