SSU CRA II

Study Start Up Associate II - Guatemala ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.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.We are currently seeking a Study Start Up Associate II 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.What you will be doingLeading the preparation and submission of regulatory documents, including clinical trial applications, ethics committee submissions, and regulatory agency communications.Coordinating and liaising with internal and external stakeholders to obtain necessary approvals and authorizations for study initiation.Managing and maintaining comprehensive and accurate records of regulatory submissions, approvals, and correspondence.Providing guidance and support to study teams on regulatory requirements and best practices for study start-up activities.Participating in process improvement initiatives to streamline study start-up processes and enhance efficiency.Your profileBachelor's degree in life sciences or a related field.Minimum of 2 years of experience in clinical research or regulatory affairs, with specific experience in study start-up activities.Strong understanding of regulatory requirements and guidelines for clinical trials, including ICH-GCP and local regulatory requirements.Excellent organizational and project management skills, with the ability to prioritize and manage multiple tasks simultaneously.Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.Employment with ICON is contingent upon having the legal right to work in the country where the role is based.Rewards & BenefitsICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.Benefits may include:Competitive base salary and performance related incentivesHealth and wellbeing programmes including medical, dental, and vision coverage where applicableRetirement and pension plansLife assurance and disability coverageEmployee assistance programmes and wellbeing resourcesLearning and development opportunities through structured training and career pathwaysBenefits may vary depending on role and location.Inclusion and AccessibilityICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.