Senior CRA - Contractor - 0.5 FTE

<h2>Overview</h2> <p>As a Clinical Research Associate (CRA) will have local responsibility for the delivery of the studies at allocated sites and be an active participant in the local study team(s). The CRA works in close collaboration with other CRAs and the Local Study Team/ Local Study Leader to ensure that study commitments are achieved in a timely and efficient manner. The CRA acts as the main contact with the study site and has the responsibility for monitoring the study conduct to ensure proper delivery of the study.</p> <h2>Responsibilities</h2> <p>ICON is currently recruiting for a Senior CRA in Czech Republic to work on a range of therapeutic areas.</p> <p> </p> <p>This particular CRA role is a client dedicated one where you will work exclusively on one sponsors trials and SOPs; you will work for a client that values their staff and puts an emphasis on career development.</p> <p>The CRA is responsible for the preparation, initiation, monitoring and closure of assigned sites in clinical studies, in compliance with sponsor's procedural documents, international guidelines such as ICH-GCP, and relevant local regulations and that the sites deliver according to their respective commitment in the individual studies.</p> <p> </p> <p>SrCRA with strong experience may take on additional responsibilities that include additional tasks associated with study management.</p> <p> </p> <p><strong><u>Responsibilities:</u></strong></p> <ul> <li>You will monitor multiple Phase I, II, III &amp; IV clinical trial sites, across different therapeutic areas. Assist other CRAs with co-monitoring activities both remote and on-site.</li> <li>You will utilise your customer service mindset with your sites focusing on delivering value, building loyalty and trust to create a positive impact and strong relationship with investigators and study coordinators where respect, knowledge and commitment to ICH/GCP guidelines are key to successful trial conduct.</li> <li>As the CRA you are the main sponsor representative, providing key project updates. You will collaborate with the team, developing commitment to study timelines and objectives through regular visits with site staff in-person and remotely.</li> <li>You will be first to review "source to CRF/eCRF," ensuring patient safety and data integrity aspect of the study.</li> <li>As the first point of contact for study sites, escalating any concerns/issues to other departments including Safety, Investigational Medicinal Product, Local Study Managers and management team as appropriate.</li> <li>Additionally, you will oversee the sites' adherence to GCP/ICH practices, ensuring quality of study conduct.</li> </ul> <p>#LI-JP3</p> <p>#LI-Remote</p> <h2>Qualifications</h2> <p><strong>To be successful in the role, you will have:</strong></p> <p> </p> <ul> <li>Bachelor’s Degree (or equivalent)</li> <li>Minimum 3 years of independent on-site monitoring experience</li> <li>Ability to travel nationally with overnight stays</li> <li>Experience conducting all types of MVs such as: Site Selection, Initiation, Routine Monitoring and Close Out Visits both remotely and on-site</li> <li>A demonstrated working knowledge of ICH/GCP Guidelines</li> <li>Excellent record-keeping skills and attention to detail</li> <li>Fluent in English and Czech</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 addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.Our benefits examples include: </p> <ul> <li>Various annual leave entitlements</li> <li>A range of health insurance offerings to suit you and your family’s needs</li> <li>Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead</li> <li>Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being</li> <li>Life assurance</li> <li>Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others</li> </ul> <p>Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefitsAt ICON, diversity, inclusion &amp; belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. We’re dedicated to providing an inclusive and accessible environment for all cand