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- Tasks: Oversee and monitor clinical trials, ensuring compliance and data quality.
- Company: Leading clinical research organisation with a focus on innovation.
- Benefits: Flexible remote work, competitive salary, and opportunities for professional growth.
- Other info: Join a dynamic team with a commitment to excellence and collaboration.
- Why this job: Make a real difference in healthcare by managing impactful clinical trials.
- Qualifications: 10+ years of CRA experience and knowledge of ICH-GCP regulations.
The predicted salary is between 55000 - 70000 £ per year.
Position Summary
CRA is responsible for the oversight and monitoring clinical trials to ensure they are conducted in compliance with the study protocol, ICH-GCP guidelines, applicable regulations, and company SOPs. CRA provides CRO oversight or monitoring of site performance, data quality, patient safety, and timely trial execution through effective site management and communication. CRA supports the Clinical Trial Manager in oversight of CRO.
Site Management & Monitoring
- Conduct targeted oversight or monitoring activities for site selection, initiation, interim monitoring, and close-out visits
- Ensure trial conduct aligns with protocol, ICH-GCP, and regulatory requirements
- Oversee review and verify source data and ensure accurate, complete, and timely data entry
- Perform risk-based monitoring activities (remote and on-site as required)
- Training and escalation for CRO CRAs when necessary
- KPI and QTL review and updates to ensure the trial is operating at the highest quality
- Develop and review tools to support the monitoring or oversight of the CRO
Regulatory & Documentation
- Support regulatory submissions and maintenance of site documentation
Data Quality & Safety
- Identify and resolve data discrepancies with site staff and data management
- Escalate quality issues and support CAPA implementation when needed
- Provide training and ongoing support to investigators and site teams
- Coordinate with central labs, imaging, and other trial vendors as needed
- Track site performance metrics (enrolment, deviations, query resolution)
Oversight of CRA activities provided by third party
- Review CRO deliverables such as monitoring visit reports, follow-up letters, trip reports, and site communication for quality and completeness
- Track CRO performance using agreed metrics (e.g., monitoring visit timeliness, query aging, protocol deviation, TMF completeness)
- Participate and attend vendor meetings and have flexibility to support the team travelling abroad.
- Ensure CRO monitors are complying to risk-based monitoring plans and study-specific monitoring requirements
- Support audit/inspection readiness by ensuring CRO monitoring documentation and site files are inspection-ready
Qualifications
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, or related field
- ~10+ years of CRA or Clinical research experience
- ~Familiarity with ICH-GCP, UK/US/EU regulations, and clinical trial documentation
- ~Experience in Oncology preferably hematological cancers
- ~Analytical mindset with the ability to use facts and data to guide decisions.
- ~Accountability and Reliability: Take ownership for performance, be dependable, and support others to achieve collective goals.
- Align on common objectives and use facts and data to reach fair, effective decisions.
- Contribute to balanced roles within the team, support delegation, and help colleagues reach their full potential.
Senior Clinical Research Associate (UK) Remote in Manchester employer: CellCentric
Contact Detail:
CellCentric Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Clinical Research Associate (UK) Remote in Manchester
✨Tip Number 1
Network like a pro! Reach out to your connections in the clinical research field, attend industry events, and join relevant online forums. We all know that sometimes it’s not just what you know, but who you know that can help you land that Senior Clinical Research Associate role.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of ICH-GCP guidelines and the latest in oncology research. We recommend practising common interview questions with a friend or even in front of the mirror. Confidence is key, and knowing your stuff will help you shine!
✨Tip Number 3
Don’t forget to showcase your analytical mindset during interviews! Be ready to discuss how you’ve used data to guide decisions in past roles. We want to see how you can bring that accountability and reliability to our team.
✨Tip Number 4
Apply directly through our website! It’s the best way to ensure your application gets seen by the right people. Plus, we love seeing candidates who are proactive and eager to join us in making a difference in clinical research.
We think you need these skills to ace Senior Clinical Research Associate (UK) Remote in Manchester
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Senior Clinical Research Associate role. Highlight your relevant experience in clinical trials, especially in oncology, and showcase your familiarity with ICH-GCP and regulatory requirements. We want to see how your background aligns with what we’re looking for!
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 can contribute to our team. Be sure to mention any specific experiences that demonstrate your accountability and reliability in past roles.
Showcase Your Analytical Skills: Since this role requires an analytical mindset, don’t forget to include examples of how you've used data to guide decisions in your previous positions. We love seeing candidates who can back up their claims with solid evidence!
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, it shows us you’re genuinely interested in joining our team at StudySmarter!
How to prepare for a job interview at CellCentric
✨Know Your Stuff
Make sure you brush up on ICH-GCP guidelines and the latest regulations in clinical trials. Being able to discuss these confidently will show that you're not just familiar with the basics but are also committed to maintaining high standards in your work.
✨Showcase Your Experience
Prepare specific examples from your past roles that highlight your experience in site management and monitoring. Talk about how you've handled data discrepancies or supported CROs, as this will demonstrate your hands-on knowledge and problem-solving skills.
✨Ask Smart Questions
Come prepared with insightful questions about the company's approach to trial oversight and their expectations for the CRA role. This shows that you're genuinely interested in the position and helps you gauge if the company aligns with your career goals.
✨Demonstrate Team Spirit
Since collaboration is key in this role, be ready to discuss how you've worked effectively within a team. Highlight instances where you've supported colleagues or contributed to collective goals, as this will reflect your accountability and reliability.