Study Start Up Associate II

🔥 2 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

👻 Ghost score 10%

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ICON plc

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1990

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

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

• Lead preparation and submission of regulatory documents, including clinical trial applications, ethics committee submissions, and regulatory agency communications • Coordinate and liaise with internal and external stakeholders to obtain approvals and authorizations for study initiation • Manage and maintain accurate records of regulatory submissions, approvals, and correspondence • Provide guidance and support to study teams on regulatory requirements and study start-up best practices • Participate in process improvement initiatives to streamline study start-up processes and enhance efficiency • Collect, prepare, review, approve, process, and track regulatory and site-level critical documents required for study site activation in accordance with applicable SOPs, regulations, guidelines, and ICH/GCP

🎯 Requirements

• 1+ years of clinical research experience in regulatory affairs, clinical research coordination, and/or study start-up activities • Experience at a clinical research site (preferred) • 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 • Proactive approach and strong willingness to learn and develop new skills • Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams • Bachelor's degree, preferably in a life sciences, healthcare, or related field • Legal right to work in the United States

🏖️ 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