UK - In Vitro Diagnostics CRA
- London
- Clinical Monitoring
- ICON Strategic Solutions
About the role
UK-Based experienced In Vitro Diagnostics CRA required to augment 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 a client focused on developing innovative medicines and diagnostics in areas such as oncology, cardiovascular, ophthalmology, immunology, CNS and infectious diseases.
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
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 CRA IVD role preferred but not required.
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
Application process
Once you find a job opening that fits your skills and interests, you can create an account, apply and check back on the progress of your application or apply for other roles. Once your application has been received, a confirmation email will be sent to your email.
Remember: this is our first time meeting you. Read the job description and highlight on your CV those experiences that we should learn about.
One of our experienced recruiters will read your profile and determine if you're fit for the role and the company. We are aware of instances where fake recruitment text messages and emails that can appear to come from ICON have been received by individuals. Always delete suspicious text messages or emails. Never give out personal financial information.
Reasonable AccomodationsDay in the life
Teaser label
Our PeopleContent type
BlogsPublish date
08/29/2023
Summary
To excel as a Clinical Research Associate (CRA) in a Clinical Research Organization (CRO), you need a combination of education, skills, and the right mindset. Brazil-based CRA II Debora shares her
Teaser label
Our PeopleContent type
BlogsPublish date
05/23/2023
Summary
How to progress as a Clinical Research AssociateTo thrive as a Clinical Research Associate (CRA), it is imperative to cultivate a multifaceted skill set and demonstrate unwavering commitment to exce
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 fulfilled?
by
Suzaita Hipolito
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