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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 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
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry, attend relevant events, and don’t be shy about asking for introductions. We all know that sometimes it’s not just what you know, but who you know that can help you land that dream job.
✨Tip Number 2
Prepare for interviews by researching the company and the role thoroughly. We recommend practising common interview questions and even doing mock interviews with friends or mentors. The more prepared you are, the more confident you’ll feel when it’s time to shine!
✨Tip Number 3
Follow up after interviews! A simple thank-you email can go a long way in showing your appreciation and keeping you top of mind. We suggest mentioning something specific from the interview to make it personal and memorable.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, we often have exclusive roles listed there that you won’t find anywhere else. So, get clicking!
We think you need these skills to ace Sr. CRA 1 - Single Sponsor Dedicated
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!
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 appreciate candidates who can think on their feet!
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 – just a few clicks and you’re done!
How to prepare for a job interview at IQVIA LLC
✨Know Your Stuff
Make sure you brush up on your knowledge of 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 a real-world setting.
✨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 the role.
✨Communicate Clearly
Since strong written and verbal communication skills are essential, practice articulating your thoughts clearly. You might even want to prepare a few questions to ask the interviewer about the team dynamics or project expectations, which shows your interest and engagement.
✨Be Organised
Bring along any necessary documents, such as your CV and references, neatly organised. Also, consider preparing a list of your own questions about the role and the company. This not only helps you stay on track during the interview but also reflects your organisational skills, which are crucial for a Senior Clinical Research Associate.
