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Clinical Research Associate

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ICON plc

Yesterday

  • Job
    Full-time
    Junior, Mid & Senior Level
  • Research & Development
    Healthcare
  • Reading
    Remote

AI generated summary

  • You need an advanced degree, significant CRA experience (Phase IV), knowledge of ICH-GCP, site management skills, proficiency in clinical systems, and strong communication abilities.
  • You will monitor sites, ensure compliance, support late phase studies, resolve issues, collaborate with teams, mentor personnel, and engage with stakeholders for successful study execution.

Requirements

  • Advanced degree in Life Sciences, Nursing, Pharmacy, or Medicine
  • Significant experience as a Clinical Research Associate, ideally within late phase / Phase IV / real-world studies
  • Experience across both investigational product (IP) and medical device trials is highly desirable
  • Strong understanding of ICH-GCP, regulatory requirements, and post-marketing study environments
  • Proven ability to manage multiple sites and competing priorities
  • Expertise in site monitoring, data integrity, and risk-based monitoring approaches
  • Proficiency in clinical systems (e.g., CTMS, EDC)
  • Willingness to travel across the UK (~6–8 days per month)
  • Excellent communication, stakeholder management, and influencing skills

Responsibilities

  • Site Monitoring & Oversight Conduct on-site and remote monitoring visits across late phase studies, ensuring compliance with protocols, ICH-GCP, regulatory requirements, and applicable device regulations.
  • Late Phase Study Delivery Support execution of post-authorisation, observational, and interventional studies, ensuring high-quality data collection and real-world evidence generation.
  • Site Performance & Issue Resolution Evaluate site performance, identify risks, and implement solutions to ensure studies are delivered on time and to quality standards.
  • Cross-Functional Collaboration Partner with project teams, medical, data management, and commercial stakeholders to ensure efficient study delivery and reporting.
  • Training & Mentorship Provide guidance and support to site personnel and junior CRAs, maintaining consistency and best practice, where applicable.
  • Stakeholder Engagement Build strong relationships with investigators and site staff to drive engagement and successful study execution.

FAQs

What is the job title for this position?

The job title is Clinical Research Associate II (CRA II) for Late Phase studies.

What type of studies will I be working on as a CRA II?

You will be working on post-marketing, real-world, and late phase studies, which include both interventional and observational studies.

What qualifications are required for this role?

An advanced degree in Life Sciences, Nursing, Pharmacy, or Medicine is required. Significant experience as a Clinical Research Associate, particularly in late phase or real-world studies, is also necessary.

Is experience with medical device trials desirable?

Yes, experience across both investigational product (IP) and medical device trials is highly desirable.

What skills are essential for this position?

Strong understanding of ICH-GCP, regulatory requirements, expertise in site monitoring, data integrity, risk-based monitoring approaches, and excellent communication and stakeholder management skills are essential.

Will I need to travel for this job?

Yes, you will need to travel across the UK approximately 6–8 days per month.

What does ICON offer in terms of benefits?

ICON offers a competitive salary, a range of health insurance options, retirement planning offerings, annual leave entitlements, an Employee Assistance Programme, life assurance, and flexible country-specific optional benefits.

How does ICON prioritize diversity and inclusion?

ICON emphasizes an inclusive environment and is dedicated to providing an accessible workplace free from discrimination and harassment, ensuring all qualified applicants receive equal consideration for employment.

What if I need accommodations during the application process?

If you require reasonable accommodations due to a medical condition or disability, you can let ICON know or submit a request to receive assistance during the application process.

Can I apply if I don't meet all the requirements?

Yes, you are encouraged to apply even if you do not meet all the requirements, as there’s a chance you may be a good fit for the role.

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ICON plc

Science & Healthcare
Industry
10,001+
Employees

Mission & Purpose

Since our foundation in Dublin, Ireland in 1990, our mission has been to help our clients to accelerate the development of drugs and devices that save lives and improve quality of life. We do this by delivering best in class information, solutions and performance, with an unyielding focus on quality at all times. We offer a full range of consulting, development and commercialisation services from a global network of offices in 53 countries. We focus our innovation on the factors that are critical to our clients – reducing time to market, reducing cost, and increasing quality – and our global team of experts has extensive experience in a broad range of therapeutic areas.