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- Tasks: Monitor clinical sites, ensuring compliance and quality in research practices.
- Company: Join IQVIA, a leader in clinical research with a mission-driven culture.
- Benefits: Gain valuable experience, competitive salary, and opportunities for professional growth.
- Why this job: Make a real impact in healthcare while developing your skills in a dynamic environment.
- Qualifications: Experience in site monitoring and knowledge of GCP and ICH guidelines required.
- Other info: Flexible travel opportunities and a chance to work on diverse clinical trials.
The predicted salary is between 30000 - 42000 £ per year.
IQVIA UK’s Site Management (multi-sponsor) team is growing and seeking junior and 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. IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
CRA2 - Multi-Sponsor Department in Manchester employer: IQVIA
Contact Detail:
IQVIA Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land CRA2 - Multi-Sponsor Department in Manchester
✨Tip Number 1
Network like a pro! Reach out to current or former employees at IQVIA through LinkedIn. A friendly chat can give us insider info and maybe even a referral, which can really boost your chances.
✨Tip Number 2
Prepare for the interview by knowing the company inside out. Familiarise yourself with their projects and values. This shows us that you’re genuinely interested and ready to make an impact!
✨Tip Number 3
Practice common interview questions, especially those related to site monitoring and GCP guidelines. We want to see how well you can articulate your experience and knowledge in real-world scenarios.
✨Tip Number 4
Don’t forget to follow up after your interview! A quick thank-you email can keep you fresh in our minds and show us your enthusiasm for the role. Plus, it’s just good manners!
We think you need these skills to ace CRA2 - Multi-Sponsor Department in Manchester
Some tips for your application 🫡
Tailor Your CV: Make sure your CV reflects the skills and experiences that match the CRA2 role. Highlight any relevant clinical trial experience and your understanding of GCP and ICH guidelines. We want to see how you can make an impact!
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 aligns with our mission at IQVIA. Keep it engaging and personal – we love a good story!
Be Honest and Clear: Remember, honesty is key in our hiring process. Ensure all the information you provide is accurate and complete. If you have gaps in your experience, don’t shy away from addressing them – we appreciate transparency!
Apply Through Our Website: We encourage you to apply directly through our website for the best chance of getting noticed. It’s straightforward and ensures your application goes straight to the right team. Let’s get started on this journey together!
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 understand the regulatory landscape and are ready to hit the ground running.
✨Showcase Your Monitoring Experience
Prepare specific examples from your past experiences where you've successfully managed clinical trial protocols. Highlight your independent on-site monitoring skills and how you've tackled challenges at diverse investigative sites. This will demonstrate your capability and confidence in the role.
✨Demonstrate Communication Skills
Since the role involves liaising with study teams and site staff, practice articulating how you establish and maintain communication lines. Share instances where your communication helped resolve issues or improved project outcomes, as this will reflect your collaborative spirit.
✨Be Ready to Discuss Recruitment Strategies
Think about how you've adapted recruitment plans in previous roles. Be prepared to discuss strategies you've used to enhance predictability in subject recruitment, as this is a key responsibility in the job. Showing that you can think critically about recruitment will set you apart.