UK - In Vitro Diagnostics CRA
- London
- Clinical Monitoring
- ICON Strategic Solutions
- Remote
Principal Talent Acquisition Business Partner
- Icon Strategic Solutions
About the role
UK-Based In Vitro Diagnostics (Senior level) CRA required to compliment the existing team of IVD CRAs.
Target candidate profiles are >BSc educated UK-based experienced CRAs (with a Lab-based background).
You will be partnering with one client focused on developing innovative medicines and diagnostics in areas such as oncology, cardiovascular, ophthalmology, immunology, CNS and infectious diseases.
You'll collaborate on impactful projects, using your expertise to enhance and contribute to the collective knowledge of our established IVD CRA team
This is an excellent and rewarding position within the client partner's long-standing team. Full training and extensive support will be provided.
The IVD Clinical Research Associate will design, plan, coordinate, and conduct all activities involved in initiating, monitoring, and completing clinical research studies for in vitro diagnostics.
Responsibilities include but are not limited to:
* Ensuring studies are conducted and documented in accordance with the study protocol, standard operating procedures, good clinical practices and other applicable regulatory requirements;
* Validating product performance claims;
* Supplying data for critical Regulatory submissions;
* Defining the functional and clinical utility of investigational products, and
* Obtaining opinions and input regarding investigational products from laboratories or customers, who may be considered key opinion leaders. The CRA is responsible for adhering to the policies of the quality system and achieving quality objectives through daily actions.
JOB FUNCTIONS/RESPONSIBILITIES
* Performing or coordinating aspects of clinical studies including site selection, study initiation, site monitoring, and study closeout. Maintaining communication with study investigators to ensure studies are completed in a timely fashion and ensuring that study objectives are met. Interfacing with cross functional staff to support post launch activities. Reviewing cases with investigators to resolve discrepancies. Ensuring that studies adhere to FDA regulations, Good Clinical Practices, IVD directives, and client policies and procedures
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EXPERIENCE, SKILLS, KNOWLEDGE REQUIREMENTS
* Excellent oral and written communication skills. Excellent planning, organizing, and interpersonal skills. Ability to work independently, make sound decisions, and to analyze and solve problems. Demonstrated experience in computer skills to include Microsoft Office, and basic templates. Medical laboratory experience stipulation. General clinical trials experience/deep understanding.
*Up to 2 years of experience in an IVD CRA role.
*Significant lab-based experience.
*Must be able to travel within UK and EU region on occasion.
EDUCATION REQUIREMENTS
* Minimum - Bachelor's degree in science or relevant field.
Medical technology degree preferred, but not required if R&D background is adequate
Impactful work. Meaningful careers. Quality rewards.
At ICON, our employees are our greatest strength. That’s why we are committed to empowering you to live your best life, both inside and outside of work. Whether your ambition is lead a global team, become a deep scientific or technical expert, work in-house with our customers or gain experience in a variety of different ICON functions, we will support you in realising your full potential. Learn more about Our Culture at ICON
Day in the life
Teaser label
A Day In The LifeContent type
BlogsPublish date
04/05/2023
Summary
Senior Clinical Research Associate Suzaita Hipolito talks about the satisfaction gained from working in Clinical Research. “What would it look like to wake up every day feeling happy and fulfil
by
Suzaita Hipolito
Teaser label
Career ProgressionContent type
BlogsPublish date
03/20/2020
Summary
Navigating the world of graduate schemes and positions can be daunting, especially if you’re not quite sure of the role or company you want to align yourself with. At ICON, we recognise what a signifi
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