Senior CRA

<h2>Overview</h2> <p>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.</p> <h2>Responsibilities</h2> <p>We are looking for a motivated <strong>Senior CRA based in the Paris/Ile-de-France area</strong> to join our sponsor dedicated CRA team!</p> <p>This role is focused on <strong>Oncology studies</strong> within a Biotechnology sponsor. </p> <p>You will demonstrate, <strong>minimum 4-5+ years experience </strong>external monitoring of commercial<strong> PHASE I studies in </strong><strong>Oncology</strong>. </p> <p> </p> <p>As a <strong>Senior</strong> <strong>CRA</strong>, you will: </p> <ul> <li>Recognize, exemplify and adhere to ICONs values which centre on our commitment to People, Clients and Performance.</li> <li>As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs. </li> <li> Ability and willingness to travel </li> <li> Expert knowledge of ICON's SOPs/WPs, ICH, GCP and appropriate regulations. </li> <li> Familiarity with ICON systems</li> <li> Maintain timelines. Ensure accuracy and completeness of data entered into ICON systems. </li> <li> Recruitment of investigators. </li> <li> Independent and proactive coordination of all the necessary activities required to set up and monitor a study, including but not limited to the following:</li> <li>Identify investigators. </li> <li>Help when requested, in preparation of regulatory submissions. </li> <li>Design of patient information sheets and consent forms. </li> <li>Ensure timely submission of protocol/consent documents for ethics/IRB approval. Pre study/placement and initiation visits. Conduct regular monitoring visits in accordance with the ICON</li> <li>site monitoring SOP/sponsor site monitoring SOP, as appropriate </li> <li> Maintain all files and documentation pertaining to studies. Motivate investigators in order to achieve recruitment targets. Complete accurate study status reports. </li> <li> Ensure the correct storage of drugs and the diligent account of all drugs in accordance with SOPs.</li> <li> Keep the Project Manager regularly informed. </li> <li> Process case record forms to the required quality standards and timelines. Deal with sponsor generated queries in a timely manner. </li> <li> Ensure the satisfactory closeout of investigator sites. </li> <li> Participate, if requested, in the preparation of and review of study documentation, e.g. draft protocols, draft CRFs, monitoring guidelines and elements of final report.</li> <li>Participate in feasibility studies for new proposals as required. Ensure correct archiving of files on completion of a study. </li> <li> Maintain patient and sponsor confidentiality.</li> <li> Assume additional responsibilities as directed by the Project Manager. </li> <li>Investigational Products (IPs) stored and managed by the site: </li> </ul> <p>Ensure storage conditions and acceptable supplies are provided </p> <p>Ensure IPs are supplied only to eligible patients o Ensure IP receipt, use and return are controlled and documented </p> <p>Ensure disposition of unused IP comply with regulatory requirement and are in accordance with the sponsor.</p> <p>Act in a lead role on a study assuming additional responsibilities as detailed/documented by the Project Manager if appropriate </p> <ul> <li> <ul> <li> Participate in data listing reviews, as applicable. </li> <li> Responsible for cost effectiveness </li> <li> Participate in training and mentoring new staff up to Clinical Research Associate level as appropriate.</li> <li> Assist with marketing the company if and when appropriate. </li> <li> Other duties as assigned.</li> </ul></li> </ul> <h2>Qualifications</h2> <p>you will need:</p> <ul> <li>Solid experience as a Senior CRA within a pharmaceutical company or CRO</li> <li><strong>Strong expertise in Oncology</strong> </li> <li><strong>Phase I experience</strong></li> <li>Excellent organizational skills and ability to adapt to a dynamic environment</li> <li>Strong IT skills and ability to multitask under pressure</li> <li>Fluency in French and professional proficiency in English</li> </ul> <p><strong>What ICON can offer you:</strong>Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addit