At a Glance
- Tasks: Monitor clinical research sites and ensure compliance with GCP and ICH guidelines.
- Company: Leading clinical research organisation focused on innovation and quality.
- Benefits: Competitive salary, flexible hours, and opportunities for professional growth.
- Other info: Collaborative team environment with a focus on career development.
- Why this job: Make a difference in healthcare while gaining valuable experience in clinical research.
- Qualifications: 1 year of monitoring experience and knowledge of clinical research regulations.
The predicted salary is between 37000 - 45000 £ per year.
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.
- 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.
Qualifications
- Requires at least 1 year of independent on-site monitoring experience of interventional studies in the UK.
- Good knowledge and skill in applying applicable clinical research regulatory requirements (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines).
- Good therapeutic and protocol knowledge as provided in company training.
- Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
Clinical Research Site Monitor – GCP/ICH Focused employer: Iqvia Uk's Site Management
As a Clinical Research Site Monitor with us, you will thrive in a dynamic and supportive work environment that prioritises professional growth and development. Our commitment to Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines ensures that you are part of a team dedicated to excellence in clinical research, while our collaborative culture fosters strong relationships and open communication. Located in the heart of the UK, we offer unique opportunities to engage with diverse study sites, enhancing your expertise and career trajectory in the clinical research field.
Contact Details:
Iqvia Uk's Site Management Recruitment Team
StudySmarter Expert Advice🤫
We think this is how you could land Clinical Research Site Monitor – GCP/ICH Focused
✨Tip Number 1
Network like a pro! Reach out to your connections in the clinical research field, attend industry events, and join relevant online groups. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by brushing up on GCP and ICH guidelines. Make sure you can discuss how you've applied these in your previous roles. We want to see that you’re not just familiar with the regulations but can also demonstrate your practical experience.
✨Tip Number 3
Showcase your problem-solving skills! During interviews, be ready to share examples of how you've tackled challenges in site monitoring or recruitment. This will highlight your ability to manage ongoing project expectations and issues effectively.
✨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 genuinely interested in joining our team and contributing to our projects.
We think you need these skills to ace Clinical Research Site Monitor – GCP/ICH Focused
Some tips for your application 🫡
Tailor Your CV:Make sure your CV highlights your relevant experience in clinical research and monitoring. We want to see how your skills align with the GCP and ICH guidelines, so don’t hold back on showcasing your expertise!
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 perfect fit for the role. We love seeing genuine enthusiasm!
Showcase Your Communication Skills:Since the role involves liaising with sites and team members, highlight any experience you have in managing relationships and communicating effectively. We value clear communication, so let us know how you excel in this area!
Apply Through Our Website:We encourage you to apply directly 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 a few clicks and you’re done!
How to prepare for a job interview at Iqvia Uk's Site Management
✨Know Your GCP and ICH Guidelines
Make sure you brush up on Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines before the interview. Being able to discuss these regulations confidently will show that you understand the core of the role and can apply them effectively in your work.
✨Demonstrate Your Monitoring Experience
Prepare specific examples from your previous monitoring experiences, especially those related to interventional studies. Highlight how you managed site visits, tracked regulatory submissions, and resolved data queries. This will help illustrate your hands-on experience and problem-solving skills.
✨Showcase Your Communication Skills
Since the role involves liaising with various stakeholders, be ready to discuss how you've established effective communication lines in past projects. Share instances where you adapted your communication style to suit different audiences, whether they were site staff or team members.
✨Prepare Questions About Site Management
Think of insightful questions regarding site management and monitoring processes. Asking about their approach to subject recruitment plans or how they handle quality issues shows your genuine interest in the role and helps you assess if the company aligns with your values.
