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 by ensuring high-quality clinical trials.
- Qualifications: 1 year of monitoring experience and knowledge of clinical research regulations.
The predicted salary is between 35000 - 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 in Wokingham 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 development and employee well-being. Our commitment to Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines ensures that you will be 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 for growth and advancement in a field that is both meaningful and impactful.
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 in Wokingham
✨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 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 that you can also demonstrate your expertise.
✨Tip Number 3
Showcase your monitoring experience! Be ready to share specific examples of how you've managed site visits and handled any challenges. This will help us see your problem-solving skills in action.
✨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 serious about joining our team.
We think you need these skills to ace Clinical Research Site Monitor – GCP/ICH Focused in Wokingham
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:As a Clinical Research Site Monitor, communication is key. In your application, highlight any experiences where you’ve effectively communicated with teams or clients. We want to know you can keep everyone on the same page!
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!
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 involving 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 study sites and team members, be ready to discuss how you've established effective communication lines in past roles. Share instances where you adapted your communication style to suit different stakeholders, ensuring project expectations were met.
✨Be Ready for Scenario Questions
Expect scenario-based questions that assess your ability to handle quality issues or recruitment challenges. Think through potential situations you might face as a Clinical Research Site Monitor and prepare your responses, focusing on your analytical and decision-making skills.
