At a Glance
- Tasks: Monitor clinical sites, ensuring adherence to protocols and regulations while supporting Oncology studies.
- Company: Join IQVIA, a leader in clinical research and healthcare intelligence.
- Benefits: Gain valuable experience, travel opportunities, and contribute to meaningful health advancements.
- Other info: Flexible travel and excellent growth opportunities in a supportive team environment.
- Why this job: Make a real impact on patient outcomes while developing your career in a dynamic field.
- Qualifications: Experience in Oncology monitoring and knowledge of GCP and ICH guidelines required.
The predicted salary is between 30000 - 40000 € per year.
IQVIA's Site Management (multi-sponsor) team are seeking a Clinical Research Associate to join us on our mission to help create a healthier world. The Clinical Research Associate will support Oncology studies and cover sites across the UK.
Responsibilities:
- Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and Good Clinical Practice.
- 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 of Oncology therapeutic area for unblinded studies.
- 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 as required.
*Please note - this role is not eligible for visa sponsorship.*
Clinical Monitoring Associate in Kimberley employer: IQVIA
At IQVIA, we pride ourselves on being an exceptional employer, offering a dynamic work culture that fosters collaboration and continuous learning. As a Clinical Monitoring Associate, you will have the opportunity to make a meaningful impact in the field of Oncology while benefiting from comprehensive training and career development programmes. Our commitment to employee growth, coupled with our mission to improve global health outcomes, makes IQVIA a truly rewarding place to advance your career.
StudySmarter Expert Advice🤫
We think this is how you could land Clinical Monitoring Associate in Kimberley
✨Tip Number 1
Network like a pro! Reach out to professionals in the clinical research field, especially those working at IQVIA. A friendly chat can open doors and give you insights that might just land you an interview.
✨Tip Number 2
Prepare for your interviews by brushing up on GCP and ICH guidelines. Show us you know your stuff! We love candidates who can discuss these topics confidently and relate them to real-world scenarios.
✨Tip Number 3
Don’t forget to follow up after your interviews! A quick thank-you email can keep you fresh in our minds and show us you’re genuinely interested in the role.
✨Tip Number 4
Apply through our website for the best chance of getting noticed. We want to see your application come through our system, so make sure you hit that 'apply' button!
We think you need these skills to ace Clinical Monitoring Associate in Kimberley
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Clinical Monitoring Associate role. Highlight your experience in site monitoring and any relevant oncology studies you've worked on. We want to see how your background aligns with our mission!
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 team. Keep it concise but impactful – we love a good story!
Showcase Your GCP Knowledge:Since Good Clinical Practice is key in this role, make sure to mention your understanding of GCP and ICH guidelines. We’re looking for candidates who can demonstrate their commitment to quality and compliance.
Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way to ensure your application gets into the right hands. Plus, it shows us you’re serious about joining our team!
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 can ensure compliance in your role.
✨Demonstrate Your Monitoring Experience
Prepare specific examples from your past experience where you've conducted site monitoring visits, especially in Oncology studies. Highlight how you adapted recruitment plans or resolved issues at sites, as this will demonstrate your hands-on experience and problem-solving skills.
✨Show Your Communication Skills
Since the role involves liaising with various stakeholders, practice articulating how you establish and maintain communication with study sites. Be ready to share examples of how you've managed expectations and resolved conflicts in previous roles.
✨Be Ready to Discuss Documentation Practices
Familiarise yourself with the importance of maintaining accurate documentation, such as visit reports and action plans. Be prepared to explain how you ensure that all site documents are filed correctly and adhere to GCP and local regulations, as this is crucial for the role.
