At a Glance
- Tasks: Monitor clinical sites and ensure compliance with regulations while driving recruitment plans.
- Company: Join IQVIA, a leader in healthcare innovation and research.
- Benefits: Competitive salary, travel opportunities, and professional growth in a dynamic environment.
- Other info: Flexible travel and excellent career advancement opportunities await you.
- Why this job: Make a real impact on health innovation while working with dedicated teams.
- Qualifications: Experience in site monitoring and knowledge of GCP and ICH guidelines required.
The predicted salary is between 40000 - 55000 € 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 employer: IQVIA Laboratories
At IQVIA, we pride ourselves on being an exceptional employer, offering a dynamic work culture that fosters innovation and collaboration. As a Senior CRA, you will benefit from extensive professional development opportunities, a supportive team environment, and the chance to make a meaningful impact on global health initiatives. Our commitment to employee well-being and career growth, combined with our strategic location, makes IQVIA a standout choice for those seeking a rewarding career in clinical research.
StudySmarter Expert Advice🤫
We think this is how you could land Senior CRA
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry, attend relevant events, and don’t be shy about asking for introductions. We all know that sometimes it’s not just what you know, but who you know that can land you that Senior CRA role.
✨Tip Number 2
Prepare for interviews by researching IQVIA and understanding their mission. We want to see your passion for accelerating innovation in healthcare. Think about how your experience aligns with their goals and be ready to share specific examples from your past roles.
✨Tip Number 3
Practice makes perfect! Conduct mock interviews with friends or use online resources to refine your answers. We recommend focusing on your site monitoring experience and how you’ve tackled challenges in previous studies to impress the interviewers.
✨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 engage directly with us. Let’s get you on board!
We think you need these skills to ace Senior CRA
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 and your knowledge of 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 you can contribute to our mission at IQVIA. Keep it engaging and relevant to the role.
Showcase Your Experience:In your application, be sure to showcase your independent on-site monitoring experience. We love seeing specific examples of how you've managed studies and dealt with challenges in the past.
Apply Through Our Website:We encourage you to apply through our website for a smoother process. It helps us keep track of your application and ensures you don’t miss any important updates from us!
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.
✨Showcase Your Monitoring Experience
Prepare specific examples from your past experience where you successfully performed site monitoring visits. Highlight how you managed issues, tracked progress, and ensured compliance with protocols. This will demonstrate your hands-on expertise and problem-solving skills.
✨Communicate Effectively
Since the role involves establishing lines of communication with sites, practice articulating how you would manage ongoing project expectations. Think about how you can convey complex information clearly and build rapport with site staff during your interview.
✨Be Ready to Discuss Recruitment Strategies
IQVIA is looking for someone who can adapt and drive subject recruitment plans. Prepare to discuss any strategies you've used in the past to enhance recruitment predictability. This will show that you can think critically and contribute to the project's success.
