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. General Summary The Clinical Research Associate (CRA) monitors the progress of clinical studies at investigative sites or remotely, ensuring clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), International Conference on Harmonization Good Clinical Practices (ICH-GCP) and all applicable regulatory requirements. 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. + Manages the investigative site staff to facilitate trial deliverables, e.g., subject enrollment, data deliverables. + 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 resolution of 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. Level-Specific Responsibilities: + 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. + May serve as preceptor, providing training to less experienced clinical team members + 2 years of experience supporting clinical trials including 1 year of on-site monitoring experience + In-depth knowledge of the drug development process + In-depth knowledge and practical utilization of ICH- GCP and applicable regulatory requirements + Sound knowledge of applicable policies and procedures, SOPs, work instructions and other guidance documents + Good spoken and written communication skills; good presentation skills + Strong interpersonal, collaboration and time management skills + High proficiency with Microsoft Office and company collaboration applications + Excellent skill in the utilization of applicable clinical systems + Excellent critical thinking skills + Excellent organizational skills + Ability to focus on detail for extended periods of time; high attention to accuracy + Ability to travel extensively + Ability to establish and maintain effective working relationships with investigative site staff Education: + Undergraduate degree or international equivalent in clinical, science, or health-related field from an accredited institution; health care professional licensure, i.e., registered nurse + Equivalent combination of education, training and relevant experience may be considered in place of the education and experience stated above. All employees must read, write and speak fluent English and host country language. 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.
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