At a Glance
- Tasks: Monitor clinical sites and ensure compliance with regulations for innovative health projects.
- Company: Join IQVIA, a leader in healthcare innovation and research.
- Benefits: Competitive salary, travel opportunities, and professional growth.
- Other info: Dynamic role with opportunities for travel and collaboration.
- Why this job: Make a real difference in healthcare while working with a dedicated team.
- Qualifications: Experience in site 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 are seeking experienced Senior CRAs to strengthen our cFSP sponsor‑dedicated team.
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.
- 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.
Senior CRA in Reading employer: IQVIA Laboratories
At IQVIA, we pride ourselves on fostering a dynamic and inclusive work environment that empowers our employees to thrive. As a Senior CRA, you will benefit from comprehensive training and development opportunities, ensuring your professional growth while contributing to our mission of advancing healthcare innovation. Located in a vibrant area, our team enjoys a collaborative culture that values flexibility and encourages open communication, making IQVIA an exceptional place to build a meaningful career.
StudySmarter Expert Advice🤫
We think this is how you could land Senior CRA in Reading
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry, attend relevant events, and don’t be shy about letting people know you’re on the lookout for a Senior CRA role. You never know who might have the inside scoop on an opportunity!
✨Tip Number 2
Prepare for interviews by brushing up on your GCP and ICH knowledge. Be ready to discuss how you've applied these guidelines in your previous roles. We want to see that you can not only talk the talk but also walk the walk!
✨Tip Number 3
Showcase your site monitoring experience! Bring examples of how you've successfully managed site visits and resolved issues. This will help us see that you’re the right fit for our cFSP sponsor-dedicated team.
✨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, it shows you’re serious about joining our mission to accelerate innovation for a healthier world!
We think you need these skills to ace Senior CRA in Reading
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 our mission at IQVIA!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Share your passion for clinical research and how you can contribute to our team. We love seeing candidates who are genuinely excited about making a difference in healthcare.
Showcase Relevant Experience:When detailing your experience, focus on specific examples that demonstrate your skills in site management and protocol adherence. We appreciate candidates who can clearly articulate their past successes and how they relate to the role.
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 serious about joining our team!
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 truly understand their importance in site monitoring.
✨Demonstrate Your Monitoring Experience
Prepare specific examples from your past experience where you performed site monitoring visits. Highlight how you handled challenges during selection, initiation, or close-out visits. This will help the interviewers see your practical knowledge and problem-solving skills in action.
✨Showcase Your Communication Skills
Since the role involves establishing regular lines of communication with sites, be ready to discuss how you’ve effectively communicated with stakeholders in previous roles. Share examples of how you managed expectations and resolved issues, as this will demonstrate your ability to collaborate and lead.
✨Be Ready for Scenario Questions
Expect scenario-based questions that test your decision-making and critical thinking skills. Think about potential quality issues you might encounter and how you would escalate them appropriately. This will show that you can think on your feet and are prepared for the realities of the job.
