At a Glance
- Tasks: Monitor clinical sites and ensure adherence to protocols for Oncology studies.
- Company: Join IQVIA, a leader in clinical research and healthcare intelligence.
- Benefits: Gain valuable experience, make an impact, and enjoy continuous learning opportunities.
- Other info: Flexible travel required; this role is not eligible for visa sponsorship.
- Why this job: Be part of a mission to create a healthier world through innovative medical treatments.
- Qualifications: Experience in Oncology monitoring and knowledge of GCP and ICH guidelines required.
The predicted salary is between 35000 - 45000 € 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 Stockport 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 Stockport
✨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 the interview by brushing up on your knowledge of Good Clinical Practice (GCP) and Oncology studies. We want you to shine, so practice common interview questions and think about how your experience aligns with the role.
✨Tip Number 3
Show your enthusiasm! When you get the chance to speak with recruiters or hiring managers, let them know why you're passionate about clinical research and how you can contribute to their mission of creating a healthier world.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen. Plus, it shows you’re serious about joining the team and making an impact in the field.
We think you need these skills to ace Clinical Monitoring Associate in Stockport
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 engaging and personal – we love to see your personality come through.
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 knowledge and commitment to maintaining high standards.
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, you’ll find all the details you need about the role and our company culture there!
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 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 expertise and problem-solving skills.
✨Communicate Effectively
Since the role involves liaising with various stakeholders, practice articulating your thoughts clearly and concisely. You might be asked about how you would handle communication with sites, so think of scenarios where you successfully managed expectations or escalated issues.
✨Be Ready to Discuss Documentation
Familiarise yourself with the types of documentation required for site management and monitoring visits. Be prepared to talk about how you ensure compliance with filing requirements and maintaining the Trial Master File (TMF) and Investigator's Site File (ISF). This shows your attention to detail and organisational skills.
