At a Glance
- Tasks: Monitor clinical sites, ensuring compliance with regulations and enhancing subject recruitment.
- Company: Join a dedicated team in a leading clinical research organisation.
- Benefits: Competitive salary, travel opportunities, and professional development in the healthcare sector.
- Other info: Dynamic role with opportunities for growth and collaboration in a supportive environment.
- Why this job: Make a real difference in clinical trials while gaining valuable experience.
- Qualifications: Experience in site monitoring and knowledge of GCP and ICH guidelines required.
The predicted salary is between 40000 - 50000 € per year.
Clinical Research Associate – South West England – cFSP sponsor-dedicated team.
Responsibilities
- Perform site monitoring visits (selection, initiation, monitoring and close‑out) 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) of 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.
- 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.
This role is not eligible for UK visa sponsorship.
Senior CRA in Bath employer: IQVIA
Join a dynamic and supportive team as a Senior Clinical Research Associate in South West England, where your expertise will be valued and your contributions recognised. Our company fosters a collaborative work culture that prioritises employee growth through continuous training and development opportunities, ensuring you stay at the forefront of clinical research. With a commitment to excellence and adherence to regulatory standards, we offer a rewarding environment that empowers you to make a meaningful impact in the field of clinical trials.
StudySmarter Expert Advice🤫
We think this is how you could land Senior CRA in Bath
✨Tip Number 1
Network like a pro! Reach out to your connections in the clinical research field, especially those who are already working as CRAs. They can provide insider info on job openings and even refer you directly to hiring managers.
✨Tip Number 2
Prepare for interviews by brushing up on GCP and ICH guidelines. Be ready to discuss how you've applied these in your previous roles. We want to see that you know your stuff and can handle the responsibilities of a Senior CRA!
✨Tip Number 3
Showcase your site monitoring experience! During interviews, share specific examples of how you've managed site visits and resolved issues. This will demonstrate your hands-on expertise and problem-solving skills.
✨Tip Number 4
Don't forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who take the initiative to connect with us directly.
We think you need these skills to ace Senior CRA in Bath
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Senior CRA role. Highlight your experience with site monitoring, GCP, and ICH guidelines. We want to see how your background aligns with what we’re looking for!
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 help us drive successful projects. Keep it engaging and relevant to the job description.
Showcase Your Communication Skills:As a CRA, communication is key! In your application, demonstrate your ability to establish lines of communication with sites and manage expectations. We love seeing examples of how you’ve done this in the past.
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 shows you’re keen on joining our team at StudySmarter!
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 experiences where you performed site monitoring visits. Highlight how you handled challenges during selection, initiation, monitoring, and close-out phases. This will demonstrate your hands-on experience and problem-solving skills.
✨Discuss Recruitment Strategies
Be ready to talk about how you've adapted and driven subject recruitment plans in previous roles. Share any innovative strategies you used to enhance predictability and meet project needs, as this is crucial for the role.
✨Emphasise Communication Skills
Since establishing regular lines of communication with sites is key, prepare to discuss how you’ve effectively managed ongoing project expectations and issues in the past. Use examples that showcase your ability to collaborate and liaise with team members and sites.
