Clinical Research Associate 1 in Reading

IVD CRA ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. As a UK home-based In Vitro Diagnostics CRA at ICON, you will contribute to our clinical trial operations function, working in an enthusiastic, dynamic team. This is a unique opportunity to move from a lab-based setting into a CRA role, embedded into a blue chip clinical diagnostics project; you will join your colleagues in leading the design, planning, co-ordinating and conducting of all activities involved in initiating, monitoring and completing clinical research studies for in vitro diagnostics.

What You Will Do: Your role will involve delivering clinical trial monitoring work to a high standard, working closely with your team and stakeholders. Key responsibilities include:

• Ensuring studies are conducted according to study protocols, operating procedures, and good clinical practice.
• Validating product performance claims.
• Supplying data for critical Regulatory submissions.
• Defining the functional and clinical utility of investigation products.
• Understanding and implementing federal regulations, helping to roll out SOPs in order to ensure that studies are adhering to FDA regulations, GCP, IVD directives and client policy.

Your Profile: You will bring relevant In Vitro Diagnostics experience, ideally from a laboratory background, along with the following qualifications and skills.

Required qualifications and experience:

• University degree in medicine, science, or equivalent.
• Practical knowledge of in vitro diagnostics and clinical trial processes.
• Excellent written and verbal communication in English.
• Good social skills enabling you to deal with queries in a timely manner.
• Willingness to travel as required from your UK base (occasionally internationally).

What ICON can offer you: Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Benefits examples include:

• Various annual leave entitlements.
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
• Life assurance.
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

Equal Opportunity and Diversity: At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here.