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, flexible travel opportunities, and contribute to meaningful health outcomes.
- Other info: Dynamic role with opportunities for continuous learning and professional growth.
- Why this job: Make a real impact in the healthcare field while advancing your career.
- 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 Dronfield employer: IQVIA
At IQVIA, we pride ourselves on being an exceptional employer, offering a dynamic work culture that fosters continuous learning and professional growth. As a Clinical Monitoring Associate, you will be part of a dedicated team making a tangible impact in the field of Oncology across the UK, with opportunities to engage in meaningful projects and collaborate with passionate colleagues. Our commitment to employee development, 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 Dronfield
✨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 Good Clinical Practice (GCP) and ICH guidelines. Show us you know your stuff and can hit the ground running in the role of Clinical Monitoring Associate.
✨Tip Number 3
Don’t just wait for job postings! Keep an eye on our website and apply directly. We love seeing proactive candidates who are eager to join our mission to create a healthier world.
✨Tip Number 4
Follow up after your interviews with a thank-you note. It’s a simple gesture that shows your enthusiasm for the role and keeps you fresh in our minds as we make decisions.
We think you need these skills to ace Clinical Monitoring Associate in Dronfield
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 expertise and commitment to quality.
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 a few clicks and you’re done!
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’re not just familiar with the terms, but that you understand their importance in clinical research.
✨Showcase Your Monitoring Experience
Prepare specific examples from your past experiences 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.
✨Communicate Effectively
Since the role involves liaising with various stakeholders, practice articulating your thoughts clearly and confidently. You might even want to role-play common scenarios with a friend to ensure you can manage ongoing project expectations and communicate effectively during the interview.
✨Be Ready to Discuss Documentation
Familiarise yourself with the types of documentation required for site management and monitoring visits. Be prepared to discuss how you maintain accurate records and ensure compliance with regulatory requirements, as this is crucial for the role and will reflect your attention to detail.
