At a Glance
- Tasks: Monitor clinical trial sites and ensure compliance with regulations and protocols.
- Company: Join IQVIA, a leader in healthcare innovation and research.
- Benefits: Competitive salary, travel opportunities, and professional development.
- Other info: Dynamic role with opportunities for growth and collaboration.
- Why this job: Make a real difference in healthcare by supporting innovative clinical trials.
- Qualifications: Experience in clinical monitoring and knowledge of GCP and ICH guidelines.
The predicted salary is between 37000 - 45000 £ per year.
Join IQVIA on our mission to accelerate innovation for a healthier world! IQVIA UK’s cFSP (sponsor-dedicated) team is growing and seeking experienced Clinical Research Associates in the UK.
Responsibilities
- Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
- Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.
- Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
- Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
- Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
- Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.
- Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
- Collaborate and liaise with study team members for project execution support as appropriate.
Requirements
- Experience of independent on-site monitoring.
- You have successfully managed multiple clinical trial protocols across diverse investigative sites.
- In depth knowledge of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
- Life science degree educated or equivalent industry experience.
- Flexibility to travel to sites.
Please note - this role is not eligible for UK visa sponsorship.
Experienced Clinical Research Associate Reading employer: IQVIA
At IQVIA, we pride ourselves on being an exceptional employer, offering a dynamic work culture that fosters innovation and collaboration. Our team in Reading is dedicated to supporting your professional growth through comprehensive training and development opportunities, while our commitment to work-life balance ensures you can thrive both personally and professionally. Join us in our mission to accelerate innovation for a healthier world, where your contributions truly make a difference.
StudySmarter Expert Advice🤫
We think this is how you could land Experienced Clinical Research Associate Reading
✨Tip Number 1
Network like a pro! Reach out to your connections in the clinical research field and let them know you're on the lookout for opportunities. You never know who might have a lead or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by brushing up on GCP and ICH guidelines. Make sure you can discuss how you've applied these in your previous roles. We want to see that you’re not just familiar with the theory, but that you can bring it to life in practice!
✨Tip Number 3
Showcase your site monitoring experience! Be ready to share specific examples of how you've managed multiple clinical trial protocols and tackled challenges at investigative sites. This will help us see your hands-on expertise.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, we love seeing candidates who take the initiative to connect directly with us.
We think you need these skills to ace Experienced Clinical Research Associate Reading
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Clinical Research Associate role. Highlight your experience with site monitoring and any specific protocols you've managed. We want to see how your background aligns with our mission!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're passionate about clinical research and how your skills can contribute to our team. Keep it engaging and relevant to the job description.
Showcase Your GCP Knowledge:Since GCP and ICH guidelines are crucial for this role, make sure to mention your familiarity with these standards in your application. We love candidates who understand the importance of compliance and quality in clinical trials!
Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it shows you’re proactive and keen to join our team!
How to prepare for a job interview at IQVIA
✨Know Your GCP and ICH Guidelines
Make sure you brush up on Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines before your interview. Being able to discuss these in detail will show that you’re not just familiar with them, but that you truly understand their importance in clinical research.
✨Showcase Your Monitoring Experience
Prepare specific examples from your past roles where you successfully managed multiple clinical trial protocols. Highlight your independent on-site monitoring experience and how you tackled challenges at different investigative sites. This will demonstrate your hands-on expertise and problem-solving skills.
✨Communicate Effectively
Since the role involves establishing regular lines of communication with sites, practice articulating how you’ve effectively communicated with various stakeholders in previous projects. Be ready to discuss how you’ve handled ongoing project expectations and resolved issues collaboratively.
✨Be Ready to Discuss Recruitment Strategies
Think about how you’ve adapted and driven subject recruitment plans in line with project needs. Be prepared to share your strategies for enhancing predictability in recruitment and how you’ve evaluated site practices to ensure adherence to protocols. This will show your proactive approach to managing studies.
