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For Companies At a Glance
- Tasks: Monitor clinical sites and ensure compliance with regulations while supporting innovative biotech projects.
- Company: Join IQVIA Biotech, a leader in transforming innovation into patient impact.
- Benefits: Gain valuable experience in clinical research with opportunities for professional growth.
- Why this job: Make a real difference in healthcare by working on cutting-edge clinical trials.
- Qualifications: 1 year of monitoring experience, preferably in Oncology, and a scientific background.
- Other info: Dynamic work environment with a focus on collaboration and innovation.
The predicted salary is between 36000 - 60000 £ per year.
Join IQVIA Biotech – Where Innovation Meets Impact. At IQVIA Biotech, we partner with visionary biotech companies to transform innovation into patient impact. With dedicated teams, deep therapeutic expertise, and a biotech tailored delivery model, we accelerate clinical development from early phase through global registrational studies.
Responsibilities
- Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
- 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.
- 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 / ICH 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.
- If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.
- If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.
Qualifications
- Minimum of 1 year of experience of on-site monitoring experience.
- Experience monitoring Oncology studies is a must.
- Bachelor's Degree in scientific discipline or health care preferred. Equivalent combination of education, training and experience may be accepted in lieu of degree.
- Basic knowledge of, and skill in applying, applicable clinical research regulatory requirements (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines).
- Good therapeutic and protocol knowledge as provided in company training.
- Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer, iPhone and iPad (where applicable).
- Written and verbal communication skills including good command of English language.
- Organizational and problem-solving skills.
- Effective time and financial management skills.
- Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
This role is not eligible for UK visa sponsorship.
Clinical Research Associate - IQVIA Biotech in Reading employer: IQVIA
Contact Detail:
IQVIA Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Clinical Research Associate - IQVIA Biotech in Reading
✨Tip Number 1
Network like a pro! Reach out to professionals in the clinical research field on LinkedIn or at industry events. We can’t stress enough how valuable personal connections can be in landing that Clinical Research Associate role.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of GCP and ICH guidelines. We recommend practising common interview questions related to site monitoring and patient recruitment strategies to show you’re ready to hit the ground running.
✨Tip Number 3
Showcase your experience with Oncology studies during interviews. We know it’s a must for this role, so highlight any relevant projects or training you've had to demonstrate your expertise and passion for the field.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive about their job search!
We think you need these skills to ace Clinical Research Associate - IQVIA Biotech in Reading
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Clinical Research Associate role. Highlight your relevant experience, especially in site monitoring and oncology studies, to show us you’re the right fit for the job.
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 your skills align with our mission at IQVIA Biotech. Keep it concise but impactful!
Showcase Your Skills: Don’t forget to highlight your computer skills and knowledge of GCP/ICH guidelines. We want to see that you can navigate the regulatory landscape and use tools like Microsoft Word and Excel effectively.
Apply Through Our Website: We encourage you to apply directly 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!
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. Being able to discuss these in detail will show that you understand the regulatory landscape and can navigate it effectively.
✨Showcase Your Monitoring Experience
Prepare specific examples from your previous monitoring experience, especially in Oncology studies. Highlight how you managed site visits, tracked recruitment plans, and resolved any issues that arose during your projects.
✨Demonstrate Strong Communication Skills
Since this role involves liaising with various stakeholders, practice articulating your thoughts clearly. Be ready to discuss how you've established effective communication lines with sites and team members in past roles.
✨Be Organised and Detail-Oriented
Bring a notebook or device to jot down important points during the interview. Show that you’re organised by discussing how you maintain documentation and manage timelines in your previous roles, as this is crucial for a Clinical Research Associate.
