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. Position Overview: The Lead Clinical Research Associate (LCRA) provides operational expertise and leadership to ensure the effective and efficient delivery of clinical site monitoring on our clinical trials. The LCRA is the key representative for clinical monitoring on the Study Team and under the direction of the Clinical Operations Study Lead (COSL), they provide leadership and direction to their assigned CRAs throughout the lifecycle of a study. The LCRA assesses clinical trial site performance, adequacy of monitoring activities, reviews monitoring visit reports and metrics, and proactively identifies and communicates site management and monitoring issues and risks to the COSL and Clinical Monitoring management team. The Lead CRA ensures the monitoring activities of their assigned study(s) are in accordance with sponsor policies and procedures, ICH/GCP and local regulations. The LCRA will report directly to the Associate Director, Clinical Monitoring. + The Lead CRA is responsible for the leadership of their assigned CRAs on a given study(s), driving the team to ensure study deliverables are met with efficiency and quality + Develops or contributes to the Clinical Monitoring Plan, monitoring tools, visit report annotations, and CRA training materials + Responsible for training the CRAs on the study and ensuring study training compliance is maintained + Reviews monitoring visit reports and metrics, including protocol deviations and follow-up items, to evaluate for compliance and trends, summarizing for the study team, escalating issues, and involved in the development of corrective and preventative actions, as needed + Responsible for reviewing clinical data (e.g. electronic case report forms, central laboratory data, risk based monitoring outputs, etc…) to ensure the CRAs are informed and managing their site’s data with quality and integrity + Responsible for ensuring CRAs maintain their sites as inspection ready, including the Trial Master File (TMF), for health authority inspections at all times + Conducts regular meetings with their CRA team and with individual CRAs to disseminate timely and relevant updates and best practices for consistency and efficiency + Conducts co-monitoring visits or other monitoring visits (site qualification visit, site initiation visit, interim monitoring visit, or close-out visit) as required by study needs + Works with the Clinical Monitoring management team on developing and updating best practices and processes, with input on discussions around quality by design and operational delivery + Bachelors or equivalent degree required, preferably in life sciences, medicine or related discipline + Minimum of 5 years Clinical Research experience, with at least 3 years of experience in clinical site monitoring + Ability to travel up to 30% of the time + Fundamental knowledge of Clinical Research, and expertise in all phases of clinical trials; comprehensive knowledge and understanding of ICH-GCP + Strong knowledge of clinical trial systems, e.g. electronic case report forms, electronic Trial Master File, and Clinical Trial Management System + Excellent management skills with a remote team, developed with a collaborative approach to problem solving, driving performance and success in a global environment + Proven effectiveness as a team leader + Outstanding interpersonal, oral and written communication skills with the ability to communicate persuasively and with clarity, flexibility and adaptability to changing requirements, resourcefulness and creativity + Demonstration of successful execution of programs in a fast-paced environment managing multiple priorities 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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