At a Glance
- Tasks: Lead clinical trials, ensuring quality and compliance across multiple sites.
- Company: Dynamic biotechnology firm focused on innovative clinical research.
- Benefits: Competitive salary, travel opportunities, and professional growth.
- Other info: Exciting role with travel across the UK and opportunities for career advancement.
- Why this job: Make a real impact in clinical research while mentoring the next generation of CRAs.
- Qualifications: Experience as a CRA with strong monitoring and mentoring skills.
The predicted salary is between 36000 - 60000 £ per year.
An exciting opportunity has arisen for an experienced Senior Clinical Research Associate to join a growing clinical operations team within a UK-based, clinical-stage biotechnology organisation. This role is suited to a senior CRA with strong hands-on monitoring experience who is confident operating at a lead level, maintaining inspection readiness, and overseeing complex site activity. You will play a key role in ensuring high-quality trial delivery, proactive risk management, and regulatory compliance across a multi-site UK study.
The position requires sustained weekly travel and biweekly on-site monitoring visits across assigned trial sites.
Key Responsibilities- Conduct advanced on-site monitoring visits, including full 100% source data verification (SDV).
- Provide oversight of monitoring quality across all sites and ensure inspection readiness at all times.
- Identify and mitigate emerging risks related to data quality, site performance, patient safety, and compliance.
- Mentor and support CRA I/II colleagues, improving monitoring efficiency and consistency.
- Build strong relationships with site staff and act as the primary escalation point for operational or quality issues.
- Lead the resolution of protocol deviations, data queries, and complex operational challenges.
- Contribute to oversight reporting, risk assessments, and study-level decision making.
- Ensure strict adherence to ICH-GCP, UK regulatory requirements, and internal SOPs.
- Significant experience working as a CRA, including responsibility for complex monitoring activities.
- Strong working knowledge of ICH-GCP, MHRA expectations, and UK clinical trial regulations.
- Proven ability to independently manage multiple sites with high monitoring intensity.
- Experience mentoring, supporting, or overseeing junior CRAs or site teams.
- Excellent problem-solving skills with the ability to anticipate and proactively mitigate risk.
- High attention to detail, strong organisational capability, and excellent communication skills.
- Ability to manage sustained weekly travel across UK trial sites.
- Full right to work in the UK (visa sponsorship not available).
- Experience in gastroenterology or IBS / CIC clinical studies.
- Exposure to PRO-driven endpoints and symptom-based GI trials.
- Full UK driving licence (advantageous but not essential).
CRA/Senior CRA in High Wycombe employer: Entrust Resource Solutions
Join a dynamic and innovative clinical-stage biotechnology organisation that prioritises employee development and fosters a collaborative work culture. With a strong focus on quality and compliance, we offer our Senior Clinical Research Associates the opportunity to lead impactful projects while enjoying flexible working arrangements and comprehensive benefits. Our commitment to mentorship and professional growth ensures that you will thrive in your career while making a meaningful contribution to advancing healthcare.
Contact Details:
Entrust Resource Solutions Recruitment Team
StudySmarter Expert Advice🤫
We think this is how you could land CRA/Senior CRA in High Wycombe
✨Tip Number 1
Network like a pro! Reach out to your connections in the clinical research field, attend industry events, and join relevant online groups. 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 brushing up on your knowledge of ICH-GCP and UK regulations. Be ready to discuss your hands-on monitoring experience and how you've tackled complex site challenges. Show them you're not just a fit for the role, but the perfect candidate!
✨Tip Number 3
Don’t underestimate the power of follow-ups! After an interview, drop a quick thank-you email to express your appreciation and reiterate your enthusiasm for the role. It keeps you fresh in their minds and shows your professionalism.
✨Tip Number 4
Apply through our website for the best chance at landing that CRA role! We love seeing applications directly from candidates who are keen on joining our team. Plus, it makes it easier for us to spot your application and get back to you quickly.
We think you need these skills to ace CRA/Senior CRA in High Wycombe
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Senior CRA role. Highlight your hands-on monitoring experience and any leadership roles you've had. We want to see how your skills match up 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 the perfect fit for our team. Mention specific experiences that relate to the key responsibilities in the job description.
Showcase Your Problem-Solving Skills:In your application, don’t forget to highlight your problem-solving abilities. Share examples of how you've tackled challenges in previous roles, especially those related to data quality and compliance.
Apply Through Our Website:We encourage you to apply through our website for a smoother process. It helps us keep track of your application and ensures you get all the updates directly from us!
How to prepare for a job interview at Entrust Resource Solutions
✨Know Your Stuff
Make sure you brush up on your knowledge of ICH-GCP, MHRA expectations, and UK clinical trial regulations. Being able to discuss these confidently will show that you're not just familiar with the basics but are ready to operate at a lead level.
✨Showcase Your Experience
Prepare specific examples from your past roles where you've successfully managed complex monitoring activities or mentored junior CRAs. This will help demonstrate your hands-on experience and ability to handle the responsibilities of the Senior CRA role.
✨Be Ready for Problem-Solving
Expect questions that assess your problem-solving skills. Think of scenarios where you've identified risks or resolved operational challenges, and be ready to explain your thought process and the outcomes.
✨Build Rapport
Since building strong relationships with site staff is key, practice how you'll connect with interviewers. Show your communication skills and ability to work collaboratively, as this will be crucial in your role as a Senior CRA.
