At a Glance
- Tasks: Monitor and support Oncology studies across the UK, ensuring quality and compliance.
- Company: Leading clinical research organisation dedicated to advancing healthcare.
- Benefits: Competitive salary, travel opportunities, and professional development in a dynamic field.
- Other info: Flexible travel required; excellent career growth potential in a vital industry.
- Why this job: Make a real difference in cancer research while gaining valuable experience.
- Qualifications: Experience in Oncology monitoring and knowledge of GCP and ICH guidelines.
The predicted salary is between 35000 - 45000 € per year.
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.
Clinical Research Associate employer: High5
As a Clinical Research Associate with us, you will be part of a dynamic team dedicated to advancing Oncology studies across the UK. We pride ourselves on fostering a collaborative work culture that prioritises employee growth through continuous training and development opportunities, ensuring you are well-equipped to excel in your role. Our commitment to innovation and excellence, combined with a supportive environment, makes us an exceptional employer for those seeking meaningful and rewarding careers in clinical research.
StudySmarter Expert Advice🤫
We think this is how you could land Clinical Research Associate
✨Tip Number 1
Network like a pro! Reach out to professionals in the oncology field through LinkedIn or industry events. We can’t stress enough how personal connections can lead to job opportunities that aren’t even advertised.
✨Tip Number 2
Prepare for interviews by researching the company and its recent projects. We recommend practising common interview questions related to clinical research and oncology. Show them you’re not just a candidate, but the right fit for their team!
✨Tip Number 3
Follow up after interviews! A quick thank-you email can go a long way. We suggest mentioning something specific from your conversation to remind them of your enthusiasm and fit for the role.
✨Tip Number 4
Don’t forget to apply through our website! We’ve got loads of opportunities waiting for you. Plus, it’s a great way to ensure your application gets seen by the right people.
We think you need these skills to ace Clinical Research Associate
Some tips for your application 🫡
Tailor Your CV:Make sure your CV highlights your experience in Oncology studies and site monitoring. We want to see how your background aligns with the responsibilities listed in the job description, so don’t hold back on showcasing relevant skills!
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 experience makes you a perfect fit for the Clinical Research Associate role. Keep it engaging and personal.
Showcase Your GCP Knowledge:Since Good Clinical Practice is crucial for this role, make sure to mention any specific training or experience you have with GCP and ICH guidelines. We love seeing candidates who are well-versed in these standards!
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, you’ll find all the details you need about the role and our company culture there!
How to prepare for a job interview at High5
✨Know Your Oncology Stuff
Make sure you brush up on your knowledge of oncology studies and the specific challenges they face. Being able to discuss recent advancements or common issues in this field will show that you're not just familiar with the role, but genuinely interested in it.
✨Master Good Clinical Practice (GCP)
Since GCP is a big part of the job, be prepared to talk about your understanding and experience with these guidelines. You might even want to have examples ready where you've applied GCP in your previous roles, as this will demonstrate your practical knowledge.
✨Show Off Your Communication Skills
As a Clinical Research Associate, you'll need to liaise with various stakeholders. Think of examples from your past where effective communication made a difference in project outcomes. This will highlight your ability to manage expectations and resolve issues proactively.
✨Be Ready to Discuss Site Management
Prepare to talk about your experience with site monitoring visits and how you've handled challenges in the past. Having specific examples of how you tracked progress, managed documentation, and ensured compliance will set you apart from other candidates.
