At a Glance
- Tasks: Join our team as a Senior In Vitro Diagnostics CRA, managing clinical research studies.
- Company: Be part of a leading company innovating in medicines and diagnostics across various health sectors.
- Benefits: Enjoy full training, extensive support, and opportunities for professional growth.
- Why this job: Make a real impact in healthcare while collaborating with experts in a supportive environment.
- Qualifications: BSc in science, lab experience, and up to 2 years in an IVD CRA role required.
- Other info: Travel within the UK and EU may be necessary.
The predicted salary is between 36000 - 60000 £ per year.
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
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UK - In Vitro Diagnostics CRA employer: ICON Strategic Solutions
Contact Detail:
ICON Strategic Solutions Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land UK - In Vitro Diagnostics CRA
✨Tip Number 1
Network with professionals in the In Vitro Diagnostics field. Attend industry conferences, webinars, or local meetups to connect with current CRAs and learn about their experiences. This can provide valuable insights and potentially lead to referrals.
✨Tip Number 2
Familiarise yourself with the latest trends and regulations in clinical research and IVD. Keeping up-to-date with industry news will not only enhance your knowledge but also demonstrate your commitment and passion for the role during interviews.
✨Tip Number 3
Prepare to discuss specific examples from your lab-based experience that highlight your problem-solving skills and ability to work independently. Tailoring your responses to reflect the responsibilities outlined in the job description can set you apart from other candidates.
✨Tip Number 4
Research the client partner's projects and areas of focus, such as oncology or cardiovascular studies. Being knowledgeable about their work will allow you to ask insightful questions during the interview and show your genuine interest in contributing to their team.
We think you need these skills to ace UK - In Vitro Diagnostics CRA
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your relevant experience in clinical research and laboratory settings. Emphasise any specific projects or roles that align with the responsibilities outlined in the job description.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for in vitro diagnostics and your understanding of the industry. Mention your experience with regulatory requirements and how you can contribute to the team’s success.
Highlight Key Skills: In your application, focus on key skills such as communication, planning, and problem-solving. Provide examples of how you've successfully used these skills in previous roles, particularly in clinical trials.
Proofread Your Application: Before submitting, carefully proofread your application materials. Check for spelling and grammatical errors, and ensure that all information is clear and concise. A polished application reflects your attention to detail.
How to prepare for a job interview at ICON Strategic Solutions
✨Showcase Your Lab Experience
Since the role requires significant lab-based experience, be prepared to discuss your previous laboratory work in detail. Highlight specific projects or techniques you've mastered that are relevant to in vitro diagnostics.
✨Demonstrate Regulatory Knowledge
Familiarise yourself with FDA regulations and Good Clinical Practices. Be ready to explain how you have ensured compliance in past studies, as this will show your understanding of the regulatory landscape.
✨Prepare for Scenario Questions
Expect questions that assess your problem-solving skills and decision-making abilities. Prepare examples from your past experiences where you successfully navigated challenges in clinical trials or lab settings.
✨Communicate Effectively
Excellent communication skills are crucial for this role. Practice articulating your thoughts clearly and concisely, especially when discussing complex scientific concepts or study protocols.