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.*
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 Sonning Common 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 access to comprehensive training and development opportunities. Our commitment to integrity and collaboration ensures that you will thrive in an environment where your contributions are valued and your career can flourish.
StudySmarter Expert Advice🤫
We think this is how you could land Clinical Monitoring Associate in Sonning Common
✨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 researching common questions for Clinical Monitoring Associates. We recommend practising your answers with a friend or in front of a mirror to boost your confidence.
✨Tip Number 3
Showcase your passion for oncology and clinical research during interviews. Share any relevant experiences or projects that highlight your commitment to making a difference in patient outcomes.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, it shows you’re serious about joining our mission to create a healthier world.
We think you need these skills to ace Clinical Monitoring Associate in Sonning Common
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 knowledge and commitment to quality in clinical trials.
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 at IQVIA!
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 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 showcase your practical knowledge 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 discuss how you manage expectations and handle conflicts, as effective communication is key in clinical research.
✨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 accuracy and compliance in maintaining Trial Master Files (TMF) and Investigator's Site Files (ISF), as this reflects your attention to detail and organisational skills.
