At a Glance
- Tasks: Monitor clinical trials and ensure compliance with regulations while supporting site management.
- Company: Join IQVIA, a leader in healthcare innovation and research.
- Benefits: Gain valuable experience, competitive salary, and opportunities for continuous learning.
- Other info: Dynamic role with travel opportunities and a chance to work with diverse teams.
- Why this job: Make a real impact in oncology research and contribute to a healthier world.
- Qualifications: Experience in clinical trial monitoring and knowledge of GCP and ICH guidelines.
The predicted salary is between 40000 - 50000 € per year.
Join IQVIA on our mission to accelerate innovation for a healthier world! IQVIA UK’s Site Management team is growing and seeking experienced Clinical Research Associates. Apply today and forge a career with greater purpose, make an impact, and never stop learning!
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.
- 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 sciences degree educated or equivalent industry experience.
- Flexibility to travel to sites.
Please note - this role is not eligible for UK visa sponsorship.
Clinical Research Associate II, Oncology in Cambridge employer: IQVIA Laboratories
At IQVIA, we are dedicated to fostering a dynamic work environment that prioritises employee growth and innovation. As a Clinical Research Associate II in Oncology, you will be part of a collaborative team that values your contributions and offers continuous learning opportunities, all while making a meaningful impact on global health. Our UK Site Management team is committed to excellence, ensuring that you have the resources and support needed to thrive in your role.
StudySmarter Expert Advice🤫
We think this is how you could land Clinical Research Associate II, Oncology in Cambridge
✨Tip Number 1
Network like a pro! Reach out to your connections in the clinical research field, especially those who work at IQVIA or similar companies. A friendly chat can open doors and give you insider info on the role.
✨Tip Number 2
Prepare for the interview by brushing up on GCP and ICH guidelines. We all know that knowledge is power, so being able to discuss these topics confidently will show you're the right fit for the Clinical Research Associate II role.
✨Tip Number 3
Showcase your experience with site monitoring visits. Be ready to share specific examples of how you've managed studies and tackled challenges. This will help us see your hands-on skills in action!
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, it shows you’re serious about joining our mission to accelerate innovation for a healthier world.
We think you need these skills to ace Clinical Research Associate II, Oncology in Cambridge
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Clinical Research Associate II role. Highlight your experience with site monitoring and any relevant clinical trial 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 oncology and how your skills can contribute to our team. Keep it concise but impactful – we love a good story!
Showcase Your GCP Knowledge:Since GCP and ICH guidelines are crucial for this role, make sure to mention your in-depth knowledge of these regulations in your application. We’re looking for candidates who understand the importance of compliance in clinical research.
Apply Through Our Website:Don’t forget to apply through our website! It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it’s super easy – just follow the prompts and submit your materials!
How to prepare for a job interview at IQVIA Laboratories
✨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 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 any challenges you faced during site monitoring visits and how you overcame them. This will demonstrate your hands-on experience and problem-solving skills.
✨Communicate Effectively
Since the role involves liaising with study team members and sites, practice articulating your thoughts clearly. You might want to role-play common scenarios where effective communication is key, such as discussing recruitment plans or addressing quality issues.
✨Be Ready to Discuss Flexibility
As travel to various sites is part of the job, be prepared to talk about your flexibility and willingness to travel. Share any previous experiences where you adapted to changing schedules or locations, which will highlight your commitment to the role.
