Study Start Up Associate II (Supporting North America region - US/CAN)<br><p>ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.</p><br><p>As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.</p><br><p></p><p>We are currently seeking a Study Start Up Associate II (Site Activation Partner) to join our diverse and dynamic team. As a Study Start Up Associate II at ICON, you will play a pivotal role in leading the initiation of clinical trials, ensuring compliance with regulatory requirements, and contributing to the advancement of innovative treatments and therapies.</p><p></p><p>In this role you will be responsible for leading or supporting operational activities from start-up to close-out, for assigned studies and investigator sites to ensure compliance with study timelines and in accordance with prevailing laws, Good Clinical Practices, and Sponsor standards.  Responsibility within a country and may span over more than one country depending on the geographical region and business needs.</p><p></p><p><b>What you will be doing </b></p><p></p><ul><li><p>Initiate and coordinate activities and essential documents management during start-up towards the compilation of a high-quality Investigator Initiation Package (IIP) leading to approval for site initiation </p></li><li><p>Support the compilation of the Central Investigator Review Board (IRB) package and submissions to approval of the study (where applicable) and other committees as per country requirements</p></li><li><p>Prepare, validate, and submit regulatory documents such as completed IIP, IRB approval forms, FDA 1572/Attestation Form, for internal regulatory approval within required timelines</p></li><li><p>Support investigators sites with local IRB workflow from preparation, submission through approval</p></li><li><p>Accurately update and maintain clinical trial systems that track site compliance and performance within project timelines</p></li><li><p>Maintain ongoing contact and communication with the study team and respond promptly to study team and investigator site requests</p></li><li><p>Coordinating and liaising with internal and external stakeholders to obtain necessary approvals and authorizations for study initiation.</p></li><li><p>Managing and maintaining comprehensive and accurate records of regulatory submissions, approvals, and correspondence</p></li><li><p>Providing guidance and support to study teams on regulatory requirements and best practices for study start-up activities.</p></li></ul><ul><li><p>Participating in process improvement initiatives to streamline study start-up processes and enhance efficiency.</p></li></ul><p></p><p><b>Your profile </b></p><ul><li><p>Bachelor's degree in life sciences or a related field.</p></li><li><p>Minimum of 2 years of experience in clinical research or regulatory affairs, with specific experience in study start-up activities.</p></li><li><p>Candidates must have very good level of English and experience working with US, as will provide support to NAM.</p></li><li><p>Strong understanding of regulatory requirements and guidelines for clinical trials, including ICH-GCP and local regulatory requirements.</p></li><li><p>Excellent organizational and project management skills, with the ability to prioritize and manage multiple tasks simultaneously.</p></li><li><p>Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams</p></li></ul><p></p><p></p><p>#LI-Remote</p><br><p>Employment with ICON is contingent upon having the legal right to work in the country where the role is based.</p><br><p><b>Rewards & Benefits</b></p><p>ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.</p><br><p>Benefits may include:</p><ul><li>Competitive base salary and performance related incentives</li><li>Health and wellbeing programmes including medical, dental, and vision coverage where applicable</li><li>Retirement and pension plans</li><li>Life assurance and disability coverage</li><li>Employee assistance programmes and wellbeing resources</li><li>Learning and development opportunities through structured training and career pathways</li></ul><br><p>Benefits may vary depending on role and location.</p><br><p>Visit our <a href="https://careers.iconplc.com/benefits" target="_blank" rel="noopener noreferrer">careers site</a> to read more about the benefits ICON offers.</p><br><p><b>Inclusion and Accessibility</b></p><p>ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.</p><br><p>If you require reasonable accommodations during the recruitment process, please let us know or submit a request <a href="https://careers.iconplc.com/reasonable-accommodations" target="_blank" rel="noopener noreferrer"><span style="color:#0875e1"><b><u>here</u></b></span></a>.</p><p style="text-align:inherit"></p><p style="text-align:left"><span>Are you a current ICON Employee? Please click </span><a href="https://wd3.myworkday.com/icon/d/task/1422$1235.htmld" target="_blank" rel="noopener noreferrer">here</a><span> to apply</span></p>