Senior Clinical Research Associate - Medical Device
ICON plc
Summary
At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON's global expertise. As the world's largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.
Job description
What You Will Do
You will lead on clinical trial monitoring tasks requiring technical depth, with a focus on quality and continuous improvement.
- Monitoring clinical trial sites to ensure adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards.
- Conducting site visits to assess site performance, resolve issues, and provide support to ensure successful trial execution.
- Collaborating with cross-functional teams to ensure timely and accurate data collection and reporting.
- Providing training and guidance to site staff and other CRAs to maintain high standards of clinical trial conduct.
- Building and maintaining effective relationships with site personnel and stakeholders to facilitate smooth trial operations.
Your Profile
You will have a strong foundation in clinical trial monitoring, with the experience of working independently and guide others.
Requirements
- Bachelor's degree 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%)
Benefits
- Competitive base salary
- Performance incentives
- Medical, Dental & Vision
- Retirement & Pension Plans
- Life Assurance & Disability
- Employee Assistance Program
- Wellbeing Resources
- Learning & Development
Company overview
ICON plc is a global leader in clinical research and healthcare intelligence, founded in Dublin, Ireland in 1990. As one of the world's largest contract research organizations (CROs), ICON provides comprehensive outsourced development services to pharmaceutical, biotechnology, and medical device companies worldwide. The company operates in 55 countries with approximately 41,900 employees, offering end-to-end solutions that span the entire product development lifecycle. ICON's service portfolio includes clinical research services, adaptive trials, biosimilars, commercialization and outcomes consulting, medical imaging, laboratory services, and strategic support for traditional and digital health technologies. The company specializes in therapeutic areas such as oncology, cardiovascular diseases, central nervous system disorders, rare diseases, and women's health. With its 2021 acquisition of PRA Health Sciences, ICON significantly expanded its capabilities and market position, becoming a dominant force in the global CRO industry. The company is publicly traded on NASDAQ under the ticker ICLR and reported $8.28 billion in revenue for 2024.