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- Tasks: Oversee clinical trials, ensuring compliance and data quality while supporting site management.
- Company: Join CellCentric, a leader in clinical research with a focus on teamwork and innovation.
- Benefits: Remote work, competitive salary, and a culture that values trust and respect.
- Other info: Dynamic team environment with opportunities for professional growth and development.
- Why this job: Make a real impact in clinical research and contribute to life-changing treatments.
- Qualifications: 10+ years of CRA experience and a degree in Life Sciences or related field.
The predicted salary is between 46000 - 52000 £ per year.
The Sr. 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. The Sr. CRA provides CRO oversight or monitoring of site performance, data quality, patient safety, and timely trial execution through effective site management and communication. The Sr. CRA supports the Clinical Trial Manager in oversight of CRO.
This individual will contribute to the success of the team and organization by delivering on role-specific responsibilities while upholding our core working behaviors of Trust and Respect, Communication and Feedback, Accountability and Reliability, Objectivity, and Team Balance and Enablement.
Key Responsibilities- 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.
- Proactively escalate to the CTMs/PD any deficiencies encountered in their daily work.
- Ensure essential documents are complete and filed appropriately (TMF/CIF/ISF).
- Support regulatory submissions and maintenance of site documentation.
- Confirm proper informed consent processes are followed and documented.
- Identify and resolve data discrepancies with site staff and data management.
- Support safety reporting processes (AEs/SAEs) and follow-up documentation.
- Escalate quality issues and support CAPA implementation when needed.
- Serve as primary point of contact for assigned sites, proactively address issues and provide solutions.
- Provide training and ongoing support to investigators and site teams.
- Collaborate with cross-functional teams (Clinical Ops, DM, Safety, QA).
- Coordinate with central labs, imaging, and other trial vendors as needed.
- Track site performance metrics (enrolment, deviations, query resolution).
- Support study timelines and contribute to process improvements.
- 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).
- Escalate site and CRO issues as needed and contribute to issue management and resolution plans.
- Participate and attend vendor meetings and have flexibility to support the team travelling abroad.
- Support oversight of TMF/eTMF completeness and filing practices, including CRO-generated documents.
- 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.
- Assist with review of CRO training compliance for assigned sites/staff.
- 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.
- Excellent organizational and time management skills.
- Strong interpersonal and communication skills.
- Ability to work independently and manage multiple sites.
- Ability to work across time zones.
- Experience in Oncology preferably hematological cancers.
- Proven ability to build trust and credibility through integrity, openness, and respect.
- Demonstrated accountability in delivering results and meeting commitments.
- Analytical mindset with the ability to use facts and data to guide decisions.
- Experience working on phase 2 and 3 registrational trials is preferred.
- Trust and Respect: Act with integrity, honesty, and openness to build strong, credible relationships.
- Communication and Feedback: Share information clearly, listen actively, and engage in a culture of constructive feedback.
- Accountability and Reliability: Take ownership for performance, be dependable, and support others to achieve collective goals.
- Objectivity: Align on common objectives and use facts and data to reach fair, effective decisions.
- Team Balance and Enablement: Contribute to balanced roles within the team, support delegation, and help colleagues reach their full potential.
At CellCentric, we believe success is built on great teams. By embodying these working behaviors, every member contributes to a high-performing, supportive, and inclusive culture where individuals and the business thrive together.
Please send your CV and covering letter to.
Senior Clinical Research Associate (UK) Remote in Hemel Hempstead 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 Hemel Hempstead
✨Tip Number 1
Network like a pro! Reach out to your connections in the clinical research field, attend relevant webinars, and join online forums. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by researching the company and its culture. Familiarise yourself with their recent projects and values, especially around trust and respect. This will help you tailor your answers and show that you're genuinely interested in being part of their team.
✨Tip Number 3
Practice your responses to common interview questions, but keep it natural. Use the STAR method (Situation, Task, Action, Result) to structure your answers, especially when discussing your experience in site management and monitoring.
✨Tip Number 4
Don’t forget to follow up after your interview! A simple thank-you email can go a long way in showing your appreciation and keeping you top of mind. Plus, it’s a great chance to reiterate your enthusiasm for the role.
We think you need these skills to ace Senior Clinical Research Associate (UK) Remote in Hemel Hempstead
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Senior Clinical Research Associate role. Highlight relevant experience, especially in clinical trials and compliance with ICH-GCP guidelines. We want to see how your background aligns with our needs!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about this role and how you embody our core working behaviours like Trust and Respect. Let us know what makes you a great fit for our team.
Showcase Your Skills: Don’t forget to highlight your organisational and communication skills. We value accountability and reliability, so share examples of how you've successfully managed multiple sites or projects in the past.
Apply Through Our Website: We encourage you to apply through our website for a smoother process. It helps us keep track of applications and ensures you don’t miss any important updates from us. We can’t wait to hear from you!
How to prepare for a job interview at CellCentric
✨Know Your Stuff
Make sure you brush up on ICH-GCP guidelines and the specific regulations relevant to clinical trials. Being able to discuss these in detail will show that you're not just familiar with the basics but are ready to dive deep into the role.
✨Showcase Your Experience
Prepare to share specific examples from your past roles, especially those related to site management and monitoring. Highlight any experience you have with phase 2 and 3 registrational trials, as well as your familiarity with oncology, particularly hematological cancers.
✨Demonstrate Communication Skills
Since this role involves a lot of collaboration, be ready to discuss how you've effectively communicated with cross-functional teams in the past. Think of examples where you’ve resolved issues or provided training to site staff.
✨Emphasise Teamwork and Accountability
Reflect on times when you contributed to team success and took ownership of your responsibilities. Be prepared to discuss how you build trust and credibility within a team, as these core behaviours are crucial for the role.