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- Tasks: Conduct site monitoring visits and ensure compliance with clinical trial protocols.
- Company: Join IQVIA, a leader in clinical research with a purpose-driven culture.
- Benefits: Gain valuable experience, competitive salary, and opportunities for professional growth.
- Why this job: Make a real impact in healthcare while learning and developing your skills.
- Qualifications: Experience in clinical trials and knowledge of GCP and ICH guidelines.
- Other info: Dynamic team environment with opportunities for travel and career advancement.
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 Reading employer: IQVIA
Contact Detail:
IQVIA Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land CRA2 - Multi-Sponsor Department in Reading
✨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 you handle real-life scenarios, so think of examples from your experience that highlight your skills.
✨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 Reading
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the CRA2 role. Highlight your experience with site monitoring and any relevant clinical trial protocols you've managed. We want to see how your background aligns with our needs!
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 multi-sponsor team. Keep it engaging and personal – we love a good story!
Showcase Your GCP Knowledge: Since GCP and ICH guidelines are crucial for this role, make sure to mention your understanding and experience with these regulations in your application. We’re looking for candidates who know their stuff and can ensure compliance!
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’s super easy – just follow the prompts and submit your materials!
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 team members and site staff, practice articulating how you establish and maintain effective communication. Think of instances where you’ve resolved issues or improved project expectations through clear dialogue. This will illustrate your collaborative spirit.
✨Be Ready to Discuss Recruitment Strategies
Understand the importance of subject recruitment plans and be prepared to discuss how you would adapt and drive these plans in line with project needs. Bring examples of how you've previously enhanced predictability in recruitment, as this is a key responsibility in the role.