Study Start Up Associate I

🔥 42 minutes ago

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ICON plc

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1990

💊 Pharmaceuticals

🧬 Biotechnology

⚕️ Healthcare Insurance

Pharmaceuticals • Biotechnology • Healthcare Insurance

ICON plc is a global provider of clinical, consulting, and commercial services across various sectors in the healthcare and pharmaceutical industries. They offer a wide range of clinical solutions, including decentralised clinical trials, cardiac safety solutions, early clinical laboratories, and medical imaging. ICON also provides technology solutions that support drug development from early phases to post-marketing. Their therapeutic expertise spans cardiovascular, oncology, internal medicine, and more, with a strong focus on transformative therapies like cell and gene therapies and biosimilars. ICON is recognized as a leading Contract Research Organisation (CRO), regularly providing thought leadership and contributing to industry publications and events. Their services are tailored to optimize clinical trials, offer regulatory intelligence, and deliver real-world evidence through robust data analysis and patient-centric solutions.

📋 Description

• Facilitate the initiation of clinical trials, ensuring compliance with regulatory requirements • Deliver site start-up and activation work to a high standard, working closely with your team and stakeholders • Assist in the preparation and submission of regulatory documents, such as clinical trial applications and ethics committee submissions • Coordinate with internal and external stakeholders to obtain necessary approvals and authorizations for study initiation • Maintain accurate and up-to-date records of regulatory submissions and approvals • Support study teams in the development of study documents, including protocols, informed consent forms, and investigator brochures • Participate in study start-up meetings and provide input on regulatory requirements and timelines

🎯 Requirements

• Bachelor's degree in life sciences or a related field • Previous experience in clinical research or regulatory affairs preferred, but not required • Strong attention to detail and organizational skills • Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams • Ability to work independently and manage multiple tasks simultaneously in a fast-paced environment • Willingness to travel as required (approximately 5%)

🏖️ Benefits

• Competitive base salary and performance related incentives • Health and wellbeing programmes including medical, dental, and vision coverage where applicable • Retirement and pension plans • Life assurance and disability coverage • Employee assistance programmes and wellbeing resources • Learning and development opportunities through structured training and career pathways