At a Glance
- Tasks: Monitor clinical sites and ensure compliance with study protocols in oncology research.
- Company: Join a leading clinical research organisation making a real impact in healthcare.
- Benefits: Full-time role with opportunities for travel, learning, and career growth.
- Other info: Dynamic work environment with a focus on continuous learning and development.
- Why this job: Make a difference in patients' lives while advancing your career in clinical research.
- 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. Apply today and forge a career with greater purpose, make an impact and never stop learning!
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 in Manchester employer: High5
Join a leading organisation in Manchester that prioritises employee growth and development, offering a dynamic work culture where your contributions truly matter. As a Clinical Research Associate, you will not only engage in meaningful oncology studies but also benefit from comprehensive training, flexible working arrangements, and a supportive team environment that fosters continuous learning and professional advancement.
StudySmarter Expert Advice🤫
We think this is how you could land Clinical Research Associate in Manchester
✨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 Good Clinical Practice (GCP) and Oncology studies. We recommend practising common interview questions with a friend or even in front of the mirror to boost your confidence!
✨Tip Number 3
Showcase your flexibility and willingness to travel during interviews. As a Clinical Research Associate, you’ll need to visit various sites, so let’s highlight your adaptability and eagerness to get out there!
✨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 in Manchester
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Clinical Research Associate role. Highlight your experience in Oncology studies and any relevant skills that match the job description. We want to see how you can make an impact!
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 background aligns with our mission at StudySmarter. Keep it engaging and personal!
Showcase Your GCP Knowledge:Since Good Clinical Practice is key for this role, be sure to mention your understanding of GCP and ICH guidelines. We’re looking for someone who knows their stuff and can ensure quality and integrity in studies.
Apply Through Our Website:Don’t forget to apply through our website! It’s the best way for us to receive your application and keep track of all the amazing candidates. Plus, it shows you’re keen on joining our team!
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 present. Familiarise yourself with recent advancements in the field, as well as any relevant GCP and ICH guidelines. This will show that you're not just a candidate, but someone genuinely interested in making an impact.
✨Demonstrate Your Monitoring Skills
Be prepared to discuss your experience with site monitoring visits. Think of specific examples where you've successfully managed recruitment plans or resolved issues at sites. Highlighting your ability to adapt and drive projects forward will resonate well with interviewers.
✨Communication is Key
Since the role involves establishing regular lines of communication with sites, be ready to talk about how you manage relationships and expectations. Share examples of how you've effectively communicated with study teams and sites to ensure smooth project execution.
✨Show Your Organisational Skills
The role requires meticulous documentation and tracking of various study elements. Prepare to discuss your organisational strategies and tools you use to keep everything in order. Mention any experience you have with maintaining Trial Master Files (TMF) and Investigator's Site Files (ISF) to demonstrate your attention to detail.
