At a Glance
- Tasks: Conduct site monitoring visits and ensure compliance with clinical trial protocols.
- Company: Join IQVIA, a leader in clinical research and healthcare innovation.
- Benefits: Gain valuable experience, travel opportunities, and contribute to meaningful health advancements.
- Other info: Flexible travel required; great opportunity for growth in the life sciences sector.
- Why this job: Make a real impact on patient outcomes while developing your career in a dynamic field.
- 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.
- 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.
Oncology Clinical Research Associate II — Site Monitoring (Travel) employer: IQVIA Laboratories
At IQVIA, we pride ourselves on being an exceptional employer that fosters a culture of continuous learning and professional growth. Our Site Management team is dedicated to making a meaningful impact in the healthcare sector, offering employees the opportunity to work on innovative clinical trials while enjoying a supportive work environment that values integrity and collaboration. With flexible travel opportunities and a commitment to employee development, joining IQVIA means becoming part of a mission-driven organisation that truly cares about your career and well-being.
StudySmarter Expert Advice🤫
We think this is how you could land Oncology Clinical Research Associate II — Site Monitoring (Travel)
✨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 researching IQVIA and understanding their mission. Tailor your answers to show how your experience aligns with their goals, especially in site monitoring and GCP compliance.
✨Tip Number 3
Practice makes perfect! Conduct mock interviews with friends or mentors to refine your responses and boost your confidence. Focus on articulating your experience with managing clinical trial protocols.
✨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 the team at IQVIA.
We think you need these skills to ace Oncology Clinical Research Associate II — Site Monitoring (Travel)
Some tips for your application 🫡
Tailor Your CV:Make sure your CV reflects the skills and experiences that match the job description. Highlight your experience in site monitoring and knowledge of GCP and ICH guidelines, as these are key for us at IQVIA.
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 background makes you a great fit for our team. Don’t forget to mention your flexibility to travel!
Be Honest and Clear:We value integrity, so be truthful in your application. Clearly outline your experiences and qualifications without exaggeration. This will help us see your genuine interest and professionalism.
Apply Through Our Website:For the best chance of success, apply directly through our website. It’s straightforward and ensures your application gets to the right people quickly. Plus, we love seeing candidates who take the initiative!
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 understand the regulatory landscape and can navigate it effectively.
✨Showcase Your Monitoring Experience
Prepare specific examples from your past roles where you successfully managed site monitoring visits. Highlight how you adapted to challenges, maintained communication with sites, and ensured compliance with protocols. This will demonstrate your hands-on experience and problem-solving skills.
✨Understand the Recruitment Process
Familiarise yourself with strategies for enhancing subject recruitment. Be ready to discuss how you've previously tracked and adapted recruitment plans to meet project needs. This shows that you can contribute to the success of clinical trials right from the start.
✨Prepare Questions for Them
Think of insightful questions to ask about their current projects or team dynamics. This not only shows your interest in the role but also helps you gauge if the company culture aligns with your values. Plus, it makes for a more engaging conversation!
