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, work with innovative teams, and contribute to meaningful health outcomes.
- Other info: Flexible travel required; this role is not eligible for visa sponsorship.
- Why this job: Make a real impact on patient health while developing your career in a dynamic environment.
- 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.*
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
Clinical Monitoring Associate in Lewes 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 meaningful impact in the field of Oncology across the UK, with opportunities to enhance your skills while contributing to groundbreaking research that improves patient outcomes. Our commitment to integrity and collaboration ensures that you will thrive in an environment where your contributions are valued and recognised.
StudySmarter Expert Advice🤫
We think this is how you could land Clinical Monitoring Associate in Lewes
✨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 Lewes
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 understand the regulatory landscape and can ensure compliance in your role.
✨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 be asked about how you would establish communication lines with sites, so think of strategies that have worked for you in the past.
✨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 handle regulatory submissions, as this is crucial for the role and shows your attention to detail.
