Senior Clinical Research Associate – Medical Device

🔥 7 minutes ago

🌽 Illinois, Iowa, +5 more states – Remote

🌽 Illinois – Remote 🌾 Iowa – Remote 🌪️ Kansas – Remote 🌾 Nebraska – Remote 🌪️ Oklahoma – Remote 🏰 Missouri – Remote 🤠 Texas – Remote

💵 $110.5k - $138.2k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

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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 clinical trial monitoring tasks requiring technical depth, with a focus on quality and continuous improvement. • Monitor clinical trial sites for adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards. • Conduct site visits to assess site performance, resolve issues, and support successful trial execution. • Collaborate with cross-functional teams to ensure timely and accurate data collection and reporting. • Provide training and guidance to site staff and other CRAs. • Build and maintain effective relationships with site personnel and stakeholders to facilitate smooth trial operations.

🎯 Requirements

• A bachelor’s degree is required, preferably a Bachelor of Science Degree in Life Science, Physical Science, Nursing or Biological Science. • 3-5 years of CRA monitoring experience in CRO/pharma environments • Strong preference for at least 1 year of medical device monitoring experience; complex pharma monitoring experience will be considered. • In-depth knowledge of FDA regulations and ICH/GCP guidelines. • Strong problem-solving skills to mitigate risks and identify issues at sites and implement effective solutions promptly. • Strong interpersonal skills to establish and maintain effective working relationships with site personnel, investigators, and internal teams. • Exceptional verbal and written communication skills, with the ability to convey complex information clearly and concisely. • Ability to tailor communication style to the needs and preferences of different stakeholders, fostering a collaborative environment. • Ability to work independently and manage multiple priorities in a dynamic environment. • A well-executed plan for communication with the study teams and sites. • Well-versed in clinical trial management; rigorous, detail-oriented, and precise in reports. • Willingness to travel as required (approximately 60%). • Legal right to work in the country where the role is based.

🏖️ 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