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- Tasks: Monitor clinical sites and ensure compliance with study protocols and regulations.
- Company: Join IQVIA, a leader in clinical research and healthcare intelligence.
- Benefits: Full-time role with opportunities for professional growth and development.
- Why this job: Make a real impact on patient outcomes while advancing your career in healthcare.
- Qualifications: Bachelor's degree and 2 years of on-site monitoring experience required.
- Other info: Dynamic work environment with a focus on innovation and collaboration.
The predicted salary is between 36000 - 60000 £ per year.
locations: Reading, Berkshire, United Kingdom
time type: Full time
posted on: Posted Today
job requisition id: R1524547
Join Us on Our Mission to Drive Healthcare Forward
IQVIA cFSP (sponsor-dedicated) are seeking experienced Senior Clinical Research Associates in the UK.
Job OverviewPerform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.
Essential Functions- 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.
- 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.
- Bachelor's Degree in scientific discipline or health care preferred.
- Requires at least 2 years of on-site monitoring experience.
- Good 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 and 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.
Please note - this role is not eligible for UK visa sponsorship.
Sr. CRA 1 - Single Sponsor Dedicated in London employer: IQVIA LLC
Contact Detail:
IQVIA LLC Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Sr. CRA 1 - Single Sponsor Dedicated in London
✨Tip Number 1
Network like a pro! Reach out to your connections in the clinical research field and let them know you're on the lookout for opportunities. You never know who might have a lead or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by researching the company and its projects. Familiarise yourself with their recent studies and be ready to discuss how your experience aligns with their goals. This shows you're genuinely interested and invested in their mission.
✨Tip Number 3
Practice your responses to common interview questions, especially those related to site management and monitoring. Use the STAR method (Situation, Task, Action, Result) to structure your answers and highlight your achievements effectively.
✨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 keen on joining our team and contributing to our mission of driving healthcare forward.
We think you need these skills to ace Sr. CRA 1 - Single Sponsor Dedicated in London
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Sr. CRA role. Highlight your relevant experience, especially any monitoring and site management work you've done. We want to see how your skills align with our mission to drive healthcare forward!
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 Skills: Don’t forget to highlight your organisational and problem-solving skills in your application. Mention specific examples where you've successfully managed projects or resolved issues. We’re all about effective time and financial management here!
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 shows you’re keen on joining our mission!
How to prepare for a job interview at IQVIA LLC
✨Know Your Stuff
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’re not just familiar with the regulations, but that you can apply them effectively in your role.
✨Showcase Your Experience
Prepare specific examples from your previous monitoring experience that highlight your problem-solving skills and ability to manage site relationships. Think about challenges you've faced and how you overcame them, as this will demonstrate your capability to handle the responsibilities of a Senior Clinical Research Associate.
✨Ask Insightful Questions
Come prepared with questions that show your interest in the company and the role. Ask about their approach to subject recruitment or how they ensure compliance with regulatory requirements. This not only shows your enthusiasm but also helps you gauge if the company is the right fit for you.
✨Be Organised
Bring along any necessary documents, such as your CV and references, and have a clear plan for how you’ll present your qualifications. Being organised reflects your ability to manage projects effectively, which is crucial for a role that involves tracking study progress and maintaining documentation.
